Fluoxetine Oral Capsule

Brand(s)
Prozac
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Dista Products Company (2015-02-04)
Oldest Current Product
1987-12-29
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\FLUOXETINE
FDAOB
ORAL\CAPSULE\FLUOXETINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\FLUOXETINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\FLUOXETINE

product(s) by strength(s)

fluoxetine 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007773104ProzacNDADista Products Company1993-01-13FLUOXETINE HYDROCHLORIDEORALCAPSULENDA018936c88f33ed-6dfb-4c5e-bc01-d8e36dd97299

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785410ANDAMylan Pharmaceuticals Inc.2008-11-17FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA078045c06f80cf-be99-0b77-ebd7-7a5f1561d4b4
2007812823ANDASandoz Inc2001-08-02FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075049db1c840d-ab22-4a4c-9ced-ae82c869dd9b
3167140351ANDANorthstar Rx Llc2009-07-01FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA090223b050b0ee-107c-4f82-8031-92ec68baa6a2
4231550028ANDAHeritage Pharmaceuticals Inc.2012-06-29FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA2013366f4e4e9f-9ded-452f-b3ef-ab6aa9c72952
5317220903ANDACamber Pharmaceuticals, Inc.2015-07-30FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA2045972a20b006-aad2-4cef-ac01-5acc557412c5
6425430725ANDAVensun Pharmaceuticals, Inc.2015-03-16FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA204597b4f37ef1-8f5e-4318-90f1-2d8f8afb669c
7501110647ANDAPliva Inc.2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA07600106d71a33-5578-4012-b11d-764f45bc1e6a
8502280113ANDASciegen Pharmaceuticals, Inc.2015-03-16FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA20459723899405-007b-48d9-82a9-a530b8e90784
9551110147ANDADr. Reddy'S Laboratories Ltd2002-10-15FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075465930a8a8c-a81a-4110-bb2e-c87e531cbd83
10658620192ANDAAurobindo Pharma Limited2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA07861945454555-7402-41cb-a452-e6a76e04f387
11763650101ANDAProdigy Health Supplier2012-06-01FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075464f719162f-cb78-487c-b172-ac10d009e6f5

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151384ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2008-05-20FLUOXETINE HYDROCHLORIDEORALCAPSULE000931042ANDA0762874410511e-48ea-4ff4-9535-752863a0ee8f
2614420151ANDACarlsbad Technology, Inc.2002-01-30FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA0760229914757b-5ef9-476e-9d0d-8da9ae53541e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157638ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2012-03-20FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA0760011cbda269-2d69-453a-abe3-734a684d835a
2009045784ANDAMajor2007-02-16FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA0760010d97a780-be38-4f5e-ba45-d3b5be262c63
3105440180ANDABlenheim Pharmacal, Inc.2012-01-18FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA07861924b0e72d-2dd3-4355-8ba4-6101b127a36b
4105440582ANDABlenheim Pharmacal, Inc.2009-12-22FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA07600137bc2c81-ac05-4a7f-aa8f-cc138dd9b895
5165900099ANDAStat Rx Usa Llc2012-03-20FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA0760014e81573a-ea76-47f8-897e-0e1d98550e46
6216950052ANDARebel Distributors Corp2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA078619a1575590-4bdd-4f66-91fb-337e5f681747
7332610184ANDAAidarex Pharmaceuticals Llc2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA07600153655048-40a3-45b2-9336-5616cfab68f0
8430630216ANDAPd-Rx Pharmaceuticals, Inc.2001-08-02FLUOXETINE HYDROCHLORIDEORALCAPSULE007812823ANDA0750495e47c25f-c865-470d-8ea3-b4f9ca2ba5ba
9430630570ANDAPd-Rx Pharmaceuticals, Inc.2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA0786197d7a196b-91de-4753-8bb6-c6d5c668952d
10433530637ANDAAphena Pharma Solutions - Tennessee, Llc2001-08-02FLUOXETINE HYDROCHLORIDEORALCAPSULE007812823ANDA0750490272727f-5c9d-4551-b1c6-28e367e5cdb9
11493490479ANDARemedyrepack Inc.2010-12-21FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA078619b3230c81-2a58-4033-848b-194dd2439843
12493490518ANDARemedyrepack Inc.2011-09-20FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA07861966a8531a-2507-402c-8919-c666ec3024c1
13499990362ANDALake Erie Medical Dba Quality Care Products Llc2011-05-24FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA0786190e817af0-85f5-46a5-82a4-e08b1f701e86
14502680333ANDAAvpak2014-08-20FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA0786190e4002ba-e7d6-560f-ce13-b8ec35e12d68
15504360924ANDAUnit Dose Services2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA07861970c1c88a-672e-4865-a556-69b1d30752f0
16511380093ANDAMed-Health Pharma, Llc2011-01-15FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA07861962c47df4-2c71-437e-b142-bc193f6277f0
17516550101ANDANorthwind Pharmaceuticals, Llc2014-11-03FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA07600126769008-c635-4b16-b8db-d2a3c9f1cc2b
18521250112ANDARemedyrepack Inc.2013-02-26FLUOXETINE HYDROCHLORIDEORALCAPSULE551110147ANDA07546544e00b9a-94e3-48db-b73c-2149dfda5797
19521250340ANDARemedyrepack Inc.2013-05-09FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA0760014e9158fa-939c-4ec3-b605-52eb722e2fc7
20538080366ANDAState Of Florida Doh Central Pharmacy2009-07-01FLUOXETINE HYDROCHLORIDEORALCAPSULE007812823ANDA075049f7994951-93d4-42cb-88f5-b8ad8e9f5037
21538080836ANDAState Of Florida Doh Central Pharmacy2012-06-01FLUOXETINE HYDROCHLORIDEORALCAPSULE003784210ANDA0752077cc62309-cb23-4888-afba-bb774658a748
22538080837ANDAState Of Florida Doh Central Pharmacy2013-01-01FLUOXETINE HYDROCHLORIDEORALCAPSULE000931042ANDA075452a63876a5-2715-4399-8237-7ee68d07704b
23548685663ANDAPhysicians Total Care, Inc.2007-11-28FLUOXETINE HYDROCHLORIDEORALCAPSULE004060661ANDA075658e1171b54-c1a3-4220-bc8a-92f49f270183
24551544846ANDACardinal Health2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA076001bb77d8a1-7c32-4f85-bdd2-a0093ec73e05
25551546890ANDACardinal Health2007-02-16FLUOXETINE HYDROCHLORIDEORALCAPSULE009045784ANDA076001a74b5d70-d673-459f-a202-2b29b85cc851
26552890613ANDAPd-Rx Pharmaceuticals, Inc.2002-10-15FLUOXETINE HYDROCHLORIDEORALCAPSULE551110147ANDA075465c44bceb0-568d-4199-a2b5-26668bc77474
27581180647ANDAClinical Solutions Wholesale2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA07600116e9809a-c3a1-4a17-8416-343b49e68ad9
28619190099ANDADirect Rx2014-01-01FLUOXETINE HYDROCHLORIDEORALCAPSULE007812823ANDA07504979dc6790-d679-4e6e-9e3f-7de8e88d4837
29631870081ANDAProficient Rx Lp2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA07861970e115cc-6e9b-4b96-a1a9-779ed51ad0a7
30631870233ANDAProficient Rx Lp2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA0760011a2a5194-b793-4c62-a177-040dad38526b
31636291609ANDABryant Ranch Prepack2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA0786193ccada47-7eb9-285d-5059-06afb4466114
32647250192ANDATya Pharmaceuticals2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA078619c85063c1-3a0a-4f50-b898-5afd3bd82fbb
33670460210ANDAContract Pharmacy Services-Pa2010-07-30FLUOXETINE HYDROCHLORIDEORALCAPSULE000931042ANDA0754528609ed02-0b30-4c82-bab1-4d51d92ec224
34686450131ANDALegacy Pharmaceutical Packaging, Llc2011-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE501110647ANDA076001aca0b44e-598d-490b-87f4-f6701d1aad9e
35687889222ANDAPreferred Pharmaceuticals, Inc.2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620192ANDA0786199e1353d7-83d1-4522-9352-5545db044a50

fluoxetine 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007773105ProzacNDADista Products Company1988-02-01FLUOXETINE HYDROCHLORIDEORALCAPSULENDA018936c88f33ed-6dfb-4c5e-bc01-d8e36dd97299

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785420ANDAMylan Pharmaceuticals Inc.2008-11-17FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA078045c06f80cf-be99-0b77-ebd7-7a5f1561d4b4
2005550877ANDABarr Laboratories Inc.2001-08-02FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA074803c509f682-d68e-490a-884d-c067e4c23a5b
3007812822ANDASandoz Inc2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075049db1c840d-ab22-4a4c-9ced-ae82c869dd9b
4167140352ANDANorthstar Rx Llc2009-07-01FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA090223b050b0ee-107c-4f82-8031-92ec68baa6a2
5231550029ANDAHeritage Pharmaceuticals Inc.2012-06-29FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA2013366f4e4e9f-9ded-452f-b3ef-ab6aa9c72952
6317220904ANDACamber Pharmaceuticals, Inc.2015-07-30FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA2045972a20b006-aad2-4cef-ac01-5acc557412c5
7425430726ANDAVensun Pharmaceuticals, Inc.2015-03-16FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA204597b4f37ef1-8f5e-4318-90f1-2d8f8afb669c
8501110648ANDAPliva Inc.2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA07600106d71a33-5578-4012-b11d-764f45bc1e6a
9502280114ANDASciegen Pharmaceuticals, Inc.2015-03-16FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA20459723899405-007b-48d9-82a9-a530b8e90784
10551110148ANDADr. Reddy'S Laboratories Ltd2002-10-15FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075465930a8a8c-a81a-4110-bb2e-c87e531cbd83
11637390493ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2010-11-18FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA09022359de2889-c3d3-4ebf-8826-13f30a3fa439
12658620193ANDAAurobindo Pharma Limited2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA07861945454555-7402-41cb-a452-e6a76e04f387
13763650102ANDAProdigy Health Supplier2012-06-01FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075464f719162f-cb78-487c-b172-ac10d009e6f5

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1614420152ANDACarlsbad Technology, Inc.2002-01-30FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA0760229914757b-5ef9-476e-9d0d-8da9ae53541e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790060ANDAKaiser Foundations Hospitals2010-04-14FLUOXETINE HYDROCHLORIDEORALCAPSULE000934356ANDA075245befdb67d-62e6-4f40-9183-30b6e0718c53
2006151357ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2010-04-29FLUOXETINE HYDROCHLORIDEORALCAPSULE000934356ANDA075245e9d6c462-84af-4371-bc05-78cb0bcb589d
3006157625ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2012-03-20FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA0760011cbda269-2d69-453a-abe3-734a684d835a
4009045785ANDAMajor2007-02-16FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA0760010d97a780-be38-4f5e-ba45-d3b5be262c63
5105440065ANDABlenheim Pharmacal, Inc.2012-01-18FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA07861924b0e72d-2dd3-4355-8ba4-6101b127a36b
6105440181ANDABlenheim Pharmacal, Inc.2009-12-22FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA07600137bc2c81-ac05-4a7f-aa8f-cc138dd9b895
7165900100ANDAStat Rx Usa Llc2010-04-29FLUOXETINE HYDROCHLORIDEORALCAPSULE000934356ANDA0752458953d343-d137-4ca5-a73f-3ceff1505b55
8165900843ProzacNDAStat Rx Usa Llc1987-12-29FLUOXETINE HYDROCHLORIDEORALCAPSULE007773105NDA0189364b8fcce1-abfc-4631-9975-9d66e178dab6
9216950053ANDARebel Distributors Corp2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA078619a1575590-4bdd-4f66-91fb-337e5f681747
10242360583ANDARemedyrepack Inc.2013-03-18FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA0760018c31b73f-9208-4507-afb1-fee9b1fe4711
11332610045ANDAAidarex Pharmaceuticals Llc2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA07861939c95b74-bdae-4e2f-82a0-8546d7f394c0
12353560728ANDALake Erie Medical Dba Quality Care Products Llc2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA078619821b8070-9f6c-4810-8eed-d42a31627d3b
13422540235ANDARebel Distributors Corp2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA0760017e82dcaa-fc75-4ea2-9465-5327e2747720
14425490599ANDAStat Rx Usa Llc2012-03-20FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA076001e5336cf0-04c9-45f2-b364-5d9132726c52
15458650451ANDAMedsource Pharmaceuticals2009-06-09FLUOXETINE HYDROCHLORIDEORALCAPSULE551110148ANDA0754650a2787f9-0166-4fa7-9f02-7d355609dabf
16493490409ANDARemedyrepack Inc.2011-07-21FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA078619215f46ea-6633-48bc-b7df-2fdb012429b7
17493490483ANDARemedyrepack Inc.2014-11-06FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA07861983abe673-87ee-4a79-a49e-2c72576735c2
18499990128ANDALake Erie Medical Dba Quality Care Products Llc2010-08-19FLUOXETINE HYDROCHLORIDEORALCAPSULE007812822ANDA07504965d1a53c-25cd-4ad0-b5bb-b6e278bd9644
19502680334ANDAAvpak2014-08-20FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA0786190e4002ba-e7d6-560f-ce13-b8ec35e12d68
20504360922ANDAUnit Dose Services2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA078619d534867a-e4ef-46ce-b61d-857387ce450a
21511380094ANDAMed-Health Pharma, Llc2011-01-15FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA07861962c47df4-2c71-437e-b142-bc193f6277f0
22516550100ANDANorthwind Pharmaceuticals, Llc2014-05-20FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA078619cb66a702-7670-4a73-98fb-0e63151a1ffb
23521250042ANDARemedyrepack Inc.2013-02-25FLUOXETINE HYDROCHLORIDEORALCAPSULE551110148ANDA07546547da8cf6-b5ef-4e74-a74c-9bd92c1af331
24521250342ANDARemedyrepack Inc.2013-06-03FLUOXETINE HYDROCHLORIDEORALCAPSULE551110148ANDA075465c5ae25a0-aee4-4ac6-b631-83d45cefcd73
25548684537ANDAPhysicians Total Care, Inc.2008-10-23FLUOXETINE HYDROCHLORIDEORALCAPSULE003784220ANDA0752076bc0214b-b6f9-463d-a689-a93e59512b60
26551541341ANDACardinal Health2007-02-16FLUOXETINE HYDROCHLORIDEORALCAPSULE009045785ANDA076001a74b5d70-d673-459f-a202-2b29b85cc851
27551545495ANDACardinal Health2011-07-11FLUOXETINE HYDROCHLORIDEORALCAPSULE510790971ANDA0752079ab14775-86b8-4a84-bec5-007dd29f3101
28551547127ANDACardinal Health2013-02-04FLUOXETINE HYDROCHLORIDEORALCAPSULE680840605ANDA078619a83f15dd-4e8a-4f00-a276-c39beade99c7
29552890610ANDAPd-Rx Pharmaceuticals, Inc.2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE007812822ANDA075049d31c9625-30c8-4efd-a31f-13930705d573
30581180648ANDAClinical Solutions Wholesale2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA07600116e9809a-c3a1-4a17-8416-343b49e68ad9
31619190100ANDADirect Rx2014-01-01FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA076001ea1c989b-3395-4e68-a300-f0f042969c4f
32631870069ANDAProficient Rx Lp2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA07861970e115cc-6e9b-4b96-a1a9-779ed51ad0a7
33636291610ANDABryant Ranch Prepack2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA078619bb06af33-8ff7-0b02-0029-d628f62e1382
34642050193ANDAReadymeds2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA078619b70f4505-ff39-4990-bb12-f9c4c1e3510c
35647250193ANDATya Pharmaceuticals2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA078619c85063c1-3a0a-4f50-b898-5afd3bd82fbb
36661160453ANDAMedvantx, Inc.2012-03-20FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA0760017125a96a-0e98-4984-8b57-a2e7a99b7b0d
37661160464ANDAMedvantx, Inc.2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA076001f1a9e2fc-f75a-46a6-82f1-c11fa0b281a2
38661160467ANDAMedvantx, Inc.2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA076001c0e3e84e-2c4e-45d9-b2e2-7c4d208eca67
39670460211ANDAContract Pharmacy Services-Pa2010-04-05FLUOXETINE HYDROCHLORIDEORALCAPSULE000934356ANDA0752454e4d8017-9c1d-41eb-affb-8046e3548be9
40670460212ANDAContract Pharmacy Services-Pa2011-01-25FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA076001a2d6beb9-bec4-4623-bcc9-7f1bfddb9f0b
41675440848ANDAAphena Pharma Solutions - Tennessee, Inc.2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE007812822ANDA0750492017acf4-ce16-4014-8105-31950f696e44
42680840605ANDAAmerican Health Packaging2013-02-04FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA0786195cfc7640-9fa4-4dec-a3b1-353eb8111852
43686450130ANDALegacy Pharmaceutical Packaging, Llc2011-01-25FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA076001b07f9eab-44ac-4667-bd46-52d736daa5d6
44687889223ANDAPreferred Pharmaceuticals, Inc.2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULE658620193ANDA078619e07fa54e-f4ee-496d-a7e9-533c85564be1
45759210648ANDALife Line Home Care Services, Inc.2012-01-16FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA07600120274ff0-f18c-4333-afab-e85ea236dea4
46762370159ANDAMckesson Contract Packaging2011-10-17FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA07600128d1233a-12b6-4b24-9ab6-079b005826ae
47762370276ANDAMckesson Contract Packaging2012-04-16FLUOXETINE HYDROCHLORIDEORALCAPSULE501110648ANDA076001894ece20-b681-4b7b-a452-113844594b31

fluoxetine 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007773107ProzacNDADista Products Company1999-06-15FLUOXETINE HYDROCHLORIDEORALCAPSULENDA018936c88f33ed-6dfb-4c5e-bc01-d8e36dd97299

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000934346ANDATeva Pharmaceuticals Usa Inc2012-08-292017-02-28FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075245c3edb2c8-acff-47f6-aa8a-21a07287cd76
2000937198ANDATeva Pharmaceuticals Usa Inc2002-01-30FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075452369dbfba-9de4-433c-8680-2ec047b8f8d9
3007812824ANDASandoz Inc2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075049db1c840d-ab22-4a4c-9ced-ae82c869dd9b
4167140353ANDANorthstar Rx Llc2009-07-01FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA090223b050b0ee-107c-4f82-8031-92ec68baa6a2
5231550030ANDAHeritage Pharmaceuticals Inc.2012-06-29FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA2013366f4e4e9f-9ded-452f-b3ef-ab6aa9c72952
6317220905ANDACamber Pharmaceuticals, Inc.2015-07-30FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA2045972a20b006-aad2-4cef-ac01-5acc557412c5
7425430727ANDAVensun Pharmaceuticals, Inc.2015-03-16FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA204597b4f37ef1-8f5e-4318-90f1-2d8f8afb669c
8498840872ANDAPar Pharmaceutical Companies, Inc.2008-12-08FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA076922ac0fe5db-e89e-4de7-9bba-15c966776f2a
9502280115ANDASciegen Pharmaceuticals, Inc.2015-03-16FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA20459723899405-007b-48d9-82a9-a530b8e90784
10551110149ANDADr. Reddy'S Laboratories Ltd2002-10-15FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA075465930a8a8c-a81a-4110-bb2e-c87e531cbd83
11633040632ANDARnabaxy Pharmaceuticals Inc.2005-07-20FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA076990bfd18a45-06cc-4281-b181-40eb5d192a9b
12637390494ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2010-11-18FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA09022359de2889-c3d3-4ebf-8826-13f30a3fa439
13658620194ANDAAurobindo Pharma Limited2008-01-31FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA07861945454555-7402-41cb-a452-e6a76e04f387
14680010129ANDABluepoint Laboratories2013-12-23FLUOXETINE HYDROCHLORIDEORALCAPSULEANDA0902236ec00661-d82c-410e-9eae-94f4642506e5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151387ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2002-01-29FLUOXETINE HYDROCHLORIDEORALCAPSULE007812824ANDA0750492ef69eb9-ef5b-431f-aeb2-34fc360a7bb5
2105440583ANDABlenheim Pharmacal, Inc.2012-01-18FLUOXETINE HYDROCHLORIDEORALCAPSULE658620194ANDA07861924b0e72d-2dd3-4355-8ba4-6101b127a36b
3216950054ANDARebel Distributors Corp2005-07-20FLUOXETINE HYDROCHLORIDEORALCAPSULE633040632ANDA076990e6c2595a-1470-4cf4-93ea-0fedf917cf85
4332610883ANDAAidarex Pharmaceuticals Llc2005-07-20FLUOXETINE HYDROCHLORIDEORALCAPSULE633040632ANDA076990eb231077-fa47-4469-b3c5-4e13d2365252
5353560729ANDALake Erie Medical Dba Quality Care Products Llc2005-07-20FLUOXETINE HYDROCHLORIDEORALCAPSULE633040632ANDA076990464d0fc2-b307-42dd-853d-9d878358d6af
6430630197ANDAPd-Rx Pharmaceuticals, Inc.2008-12-08FLUOXETINE HYDROCHLORIDEORALCAPSULE498840872ANDA07692202e761f7-24e4-4685-8fb5-0fe9cbbff8f7
7499990886ANDALake Erie Medical Dba Quality Care Products Llc2011-11-07FLUOXETINE HYDROCHLORIDEORALCAPSULE498840872ANDA0769225e814a91-4bb2-4c8d-bdb5-c64ce5babf07
8502680335ANDAAvpak2014-08-20FLUOXETINE HYDROCHLORIDEORALCAPSULE658620194ANDA0786190e4002ba-e7d6-560f-ce13-b8ec35e12d68
9504360923ANDAUnit Dose Services2005-07-20FLUOXETINE HYDROCHLORIDEORALCAPSULE633040632ANDA0769906b8ebc39-da88-4491-bbf0-9be758c2ddfc
10511380095ANDAMed-Health Pharma, Llc2011-01-15FLUOXETINE HYDROCHLORIDEORALCAPSULE658620194ANDA07861962c47df4-2c71-437e-b142-bc193f6277f0
11548684562ANDAPhysicians Total Care, Inc.2008-07-25FLUOXETINE HYDROCHLORIDEORALCAPSULE003784350ANDA0752076bc0214b-b6f9-463d-a689-a93e59512b60
12581180632ANDAClinical Solutions Wholesale2005-07-20FLUOXETINE HYDROCHLORIDEORALCAPSULE633040632ANDA076990cfdfd696-3185-48bb-ac50-f4a2ed512991
13619190490ANDADirect Rx2015-01-01FLUOXETINE HYDROCHLORIDEORALCAPSULE633040632ANDA07699062e08a06-2f62-42aa-828f-5c2d1415657e
14631870089ANDAProficient Rx Lp2005-07-20FLUOXETINE HYDROCHLORIDEORALCAPSULE633040632ANDA076990e3e8aa9d-9daf-4565-85c9-a8d79c46128b
15636293312ANDABryant Ranch Prepack2008-12-08FLUOXETINE HYDROCHLORIDEORALCAPSULE498840872ANDA0769221dc008e7-5b9b-ddcd-c369-9dc080bbd00b
16680840101ANDAAmerican Health Packaging2013-12-10FLUOXETINE HYDROCHLORIDEORALCAPSULE658620194ANDA0786195cfc7640-9fa4-4dec-a3b1-353eb8111852

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drugin other drug docs
1ANDA074803FLUOXETINE HYDROCHLORIDEBARR LABORATORIES INC2001-08-02ANDA074803_001, ANDA074803_002Fluoxetine Oral Tablet
2ANDA075049FLUOXETINE HYDROCHLORIDESANDOZ INC2001-08-02ANDA075049_001, ANDA075049_002, ANDA075049_003Fluoxetine Oral Tablet
3ANDA075207FLUOXETINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2002-01-30ANDA075207_001, ANDA075207_002, ANDA075207_003Fluoxetine Oral Tablet
4ANDA075245FLUOXETINE HYDROCHLORIDEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2002-01-31ANDA075245_001, ANDA075245_002, ANDA075245_003Fluoxetine Oral Tablet
5ANDA075452FLUOXETINE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2002-01-29ANDA075452_001, ANDA075452_002, ANDA075452_003Fluoxetine Oral Tablet
6ANDA075464FLUOXETINE HYDROCHLORIDELANDELA PHARMACEUTICAL2002-01-30ANDA075464_001, ANDA075464_002Fluoxetine Oral Tablet
7ANDA075465FLUOXETINE HYDROCHLORIDEDR REDDYS LABORATORIES LTD2001-08-02ANDA075465_001, ANDA075465_002, ANDA075465_003Fluoxetine Oral Tablet
8ANDA075577FLUOXETINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2002-01-29ANDA075577_001, ANDA075577_002Fluoxetine Oral Tablet
9ANDA075658FLUOXETINE HYDROCHLORIDEMALLINCKRODT INC2002-01-29ANDA075658_001, ANDA075658_002Fluoxetine Oral Tablet
10ANDA075662FLUOXETINETrueWATSON LABORATORIES INC2002-01-29ANDA075662_001, ANDA075662_002Fluoxetine Oral Tablet
11ANDA075787FLUOXETINETrueMUTUAL PHARMACAL CO2002-01-29ANDA075787_001, ANDA075787_002Fluoxetine Oral Tablet
12ANDA075807FLUOXETINE HYDROCHLORIDETrueSANDOZ INC2002-01-29ANDA075807_001, ANDA075807_002Fluoxetine Oral Tablet
13ANDA076001FLUOXETINE HYDROCHLORIDETEVA PHARMACEUTICALS USA2002-01-29ANDA076001_001, ANDA076001_002Fluoxetine Oral Tablet
14ANDA076022FLUOXETINE HYDROCHLORIDETrueCARLSBAD TECHNOLOGY INC2002-01-30ANDA076022_001, ANDA076022_002Fluoxetine Oral Tablet
15ANDA076165FLUOXETINE HYDROCHLORIDETrueCHINA RESOURCES DOUBLE CRANE PHARMACEUTICAL CO LTD2002-02-01ANDA076165_001, ANDA076165_002Fluoxetine Oral Tablet
16ANDA076251FLUOXETINE HYDROCHLORIDETrueBARR LABORATORIES INC2005-05-18ANDA076251_001Fluoxetine Oral Tablet
17ANDA076287FLUOXETINE HYDROCHLORIDETrueANI PHARMACEUTICALS INC2008-05-20ANDA076287_001, ANDA076287_002Fluoxetine Oral Tablet
18ANDA076922FLUOXETINE HYDROCHLORIDEPAR PHARMACEUTICAL INC2004-12-16ANDA076922_001, ANDA076922_002, ANDA076922_003Fluoxetine Oral Tablet
19ANDA076990FLUOXETINE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES LTD2004-12-13ANDA076990_001Fluoxetine Oral Tablet
20ANDA077469FLUOXETINE HYDROCHLORIDETrueSANDOZ INC2008-11-17ANDA077469_001, ANDA077469_002Fluoxetine Oral Tablet
21ANDA078045FLUOXETINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2008-11-17ANDA078045_001, ANDA078045_002Fluoxetine Oral Tablet
22ANDA078143FLUOXETINE HYDROCHLORIDETrueWOCKHARDT LTD2008-01-16ANDA078143_001, ANDA078143_002, ANDA078143_003Fluoxetine Oral Tablet
23ANDA078619FLUOXETINE HYDROCHLORIDEAUROBINDO PHARMA LTD2008-01-31ANDA078619_001, ANDA078619_002, ANDA078619_003Fluoxetine Oral Tablet
24ANDA090223FLUOXETINE HYDROCHLORIDEALEMBIC PHARMACEUTICALS LTD2009-03-19ANDA090223_001, ANDA090223_002, ANDA090223_003Fluoxetine Oral Tablet
25ANDA201336FLUOXETINE HYDROCHLORIDEHERITAGE PHARMACEUTICALS INC2012-10-01ANDA201336_001, ANDA201336_002, ANDA201336_003Fluoxetine Oral Tablet
26ANDA204597FLUOXETINE HYDROCHLORIDESCIEGEN PHARMACEUTICALS INC2015-03-16ANDA204597_001, ANDA204597_002, ANDA204597_003Fluoxetine Oral Tablet
27NDA018936PROZACELI LILLY AND CO1987-12-29p6960577, PROZAC AND OLANZAPINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTSNEW PATIENT POPULATION [2016-07-26]NDA018936_001, NDA018936_003, NDA018936_004, NDA018936_006, NDA018936_007, NDA018936_008Fluoxetine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074803_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12001-08-02FLUOXETINE HYDROCHLORIDE
2ANDA074803_002RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-30FLUOXETINE HYDROCHLORIDE
3ANDA075049_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12001-08-02FLUOXETINE HYDROCHLORIDE
4ANDA075049_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
5ANDA075049_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2002-01-29FLUOXETINE HYDROCHLORIDE
6ANDA075207_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-30FLUOXETINE HYDROCHLORIDE
7ANDA075207_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-30FLUOXETINE HYDROCHLORIDE
8ANDA075207_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2007-05-25FLUOXETINE HYDROCHLORIDE
9ANDA075245_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-31FLUOXETINE HYDROCHLORIDE
10ANDA075245_002RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-31FLUOXETINE HYDROCHLORIDE
11ANDA075245_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2004-09-28FLUOXETINE HYDROCHLORIDE
12ANDA075452_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
13ANDA075452_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
14ANDA075452_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2002-01-29FLUOXETINE HYDROCHLORIDE
15ANDA075464_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-30FLUOXETINE HYDROCHLORIDE
16ANDA075464_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-30FLUOXETINE HYDROCHLORIDE
17ANDA075465_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
18ANDA075465_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
19ANDA075465_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2001-08-02FLUOXETINE HYDROCHLORIDE
20ANDA075577_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
21ANDA075577_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
22ANDA075658_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
23ANDA075658_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
24ANDA075662_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE
25ANDA075662_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE
26ANDA075787_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE
27ANDA075787_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE
28ANDA075807_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE HYDROCHLORIDE
29ANDA075807_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE HYDROCHLORIDE
30ANDA076001_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
31ANDA076001_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
32ANDA076022_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2002-01-30FLUOXETINE HYDROCHLORIDE
33ANDA076022_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2002-01-30FLUOXETINE HYDROCHLORIDE
34ANDA076165_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2002-02-01FLUOXETINE HYDROCHLORIDE
35ANDA076165_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2002-02-01FLUOXETINE HYDROCHLORIDE
36ANDA076251_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalse2005-05-18FLUOXETINE HYDROCHLORIDE
37ANDA076287_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2008-05-20FLUOXETINE HYDROCHLORIDE
38ANDA076287_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2008-05-20FLUOXETINE HYDROCHLORIDE
39ANDA076922_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2004-12-16FLUOXETINE HYDROCHLORIDE
40ANDA076922_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2004-12-16FLUOXETINE HYDROCHLORIDE
41ANDA076922_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2004-12-16FLUOXETINE HYDROCHLORIDE
42ANDA076990_001RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2004-12-13FLUOXETINE HYDROCHLORIDE
43ANDA077469_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2008-11-17FLUOXETINE HYDROCHLORIDE
44ANDA077469_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2008-11-17FLUOXETINE HYDROCHLORIDE
45ANDA078045_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB22008-11-17FLUOXETINE HYDROCHLORIDE
46ANDA078045_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULETrue2008-11-17FLUOXETINE HYDROCHLORIDE
47ANDA078143_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2008-01-16FLUOXETINE HYDROCHLORIDE
48ANDA078143_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2008-01-16FLUOXETINE HYDROCHLORIDE
49ANDA078143_003discontinuedFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalse2008-01-16FLUOXETINE HYDROCHLORIDE
50ANDA078619_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12008-01-31FLUOXETINE HYDROCHLORIDE
51ANDA078619_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12008-01-31FLUOXETINE HYDROCHLORIDE
52ANDA078619_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2008-01-31FLUOXETINE HYDROCHLORIDE
53ANDA090223_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12009-03-19FLUOXETINE HYDROCHLORIDE
54ANDA090223_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12009-03-19FLUOXETINE HYDROCHLORIDE
55ANDA090223_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2009-03-19FLUOXETINE HYDROCHLORIDE
56ANDA201336_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12012-10-01FLUOXETINE HYDROCHLORIDE
57ANDA201336_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12012-10-01FLUOXETINE HYDROCHLORIDE
58ANDA201336_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2012-10-01FLUOXETINE HYDROCHLORIDE
59ANDA204597_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12015-03-16FLUOXETINE HYDROCHLORIDE
60ANDA204597_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12015-03-16FLUOXETINE HYDROCHLORIDE
61ANDA204597_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2015-03-16FLUOXETINE HYDROCHLORIDE
62NDA018936_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB11987-12-29PROZAC
63NDA018936_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULETrueAB1999-06-15PROZAC
64NDA018936_004discontinuedFLUOXETINE HYDROCHLORIDE (EQ 60MG BASE)ORALCAPSULEFalse1999-06-15PROZAC
65NDA018936_006RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB11992-12-23PROZAC
66NDA018936_007discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2000-07-06PROZAC
67NDA018936_008discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2000-07-06PROZAC

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6960577 (view patent)2017-11-01NDA018936, NDA020592, NDA021086, NDA021520olanzapine Oral Tablet
Fluoxetine Oral Tablet
Fluoxetine / olanzapine Oral Capsule
olanzapine Disintegrating Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10272727f-5c9d-4551-b1c6-28e367e5cdb9 (view SPL)These highlights do not include all the information needed to use FLUOXETINE safely and effectively. See full prescribing information for FLUOXETINE.Initial U.S. Approval: 1987prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2012-11-091433530637
202e761f7-24e4-4685-8fb5-0fe9cbbff8f7 (view SPL)These highlights do not include all the information needed to use Fluoxetine Capsules, USP. See full prescribing information for Fluoxetine Capsules, USP and Initial U.S. ApprovalprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-06-216430630197
306d71a33-5578-4012-b11d-764f45bc1e6a (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.FLUOXETINE CAPSULES USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionPliva Inc.2015-04-2417501110647, 501110648
40a2787f9-0166-4fa7-9f02-7d355609dabf (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine capsules safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionMedsource Pharmaceuticals2012-07-243458650451
50d97a780-be38-4f5e-ba45-d3b5be262c63 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionMajor2015-02-139009045784, 009045785
60e4002ba-e7d6-560f-ce13-b8ec35e12d68 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP. Fluoxetine Capsules, USP for Oral UseInitial U.S. Approval: 1987prescriptionHuman PrescriptionAvpak2014-09-242502680333, 502680334, 502680335
70e817af0-85f5-46a5-82a4-e08b1f701e86 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, repack2011-05-243024499990362
816e9809a-c3a1-4a17-8416-343b49e68ad9 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987xprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-08-073581180647, 581180648
91a2a5194-b793-4c62-a177-040dad38526b (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.FLUOXETINE CAPSULES USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-09-011631870233
101cbda269-2d69-453a-abe3-734a684d835a (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-03-2710006157625, 006157638
111dc008e7-5b9b-ddcd-c369-9dc080bbd00b (view SPL)These highlights do not include all the information needed to use Fluoxetine Capsules, USP. see full prescribing information for Fluoxetine Capsules, USP and Initial U.S. ApprovalprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2008-12-081636293312
122017acf4-ce16-4014-8105-31950f696e44 (view SPL)These highlights do not include all the information needed to use FLUOXETINE CAPSULES USP safely and effectively. See full prescribing information for FLUOXETINE CAPSULES USP.FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2014-06-302675440848
1320274ff0-f18c-4333-afab-e85ea236dea4 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionLife Line Home Care Services, Inc.REPACK, relabel2012-01-161759210648
14215f46ea-6633-48bc-b7df-2fdb012429b7 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-07-211493490409
1523899405-007b-48d9-82a9-a530b8e90784 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionSciegen Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2015-11-052502280113, 502280114, 502280115
1624b0e72d-2dd3-4355-8ba4-6101b127a36b (view SPL)These highlights do not include all the information needed to use fluoxetine capsules safely and effectively. See full prescribing information for fluoxetine capsules. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-173105440065, 105440180, 105440583
1726769008-c635-4b16-b8db-d2a3c9f1cc2b (view SPL)FluoxetineprescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-11-131516550101
1828d1233a-12b6-4b24-9ab6-079b005826ae (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionMckesson Contract PackagingREPACK2010-11-041762370159
192a20b006-aad2-4cef-ac01-5acc557412c5 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE, PACK2015-07-301317220903, 317220904, 317220905
202ef69eb9-ef5b-431f-aeb2-34fc360a7bb5 (view SPL)These highlights do not include all the information needed to use FLUOXETINE safely and effectively. See full prescribing information for FLUOXETINE.Initial U.S. Approval: 1987prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-03-193006151387
21369dbfba-9de4-433c-8680-2ec047b8f8d9 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-03-1313000937198
2237bc2c81-ac05-4a7f-aa8f-cc138dd9b895 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE CAPSULES USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-044105440181, 105440582
2339c95b74-bdae-4e2f-82a0-8546d7f394c0 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP. Fluoxetine Capsules, USP for Oral UseInitial U.S. Approval: 1987prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-021332610045
243ccada47-7eb9-285d-5059-06afb4466114 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-183636291609
254410511e-48ea-4ff4-9535-752863a0ee8f (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Fluoxetine capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2010-07-291006151384
2644e00b9a-94e3-48db-b73c-2149dfda5797 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine capsules safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2013-02-262521250112
2745454555-7402-41cb-a452-e6a76e04f387 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules safely and effectively. See full prescribing information for fluoxetine capsules. FLUOXETINE capsules, USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-0515658620192, 658620193, 658620194
28464d0fc2-b307-42dd-853d-9d878358d6af (view SPL)These highlights do not include all the information needed to use fluoxetine tablets, USP safely and effectively. See full prescribing information for fluoxetine tablets, USP. Fluoxetine capsules, USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2014-04-173979353560729
2947da8cf6-b5ef-4e74-a74c-9bd92c1af331 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine capsules safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2013-02-252521250042
304b8fcce1-abfc-4631-9975-9d66e178dab6 (view SPL)Prozac (Fluoxetine hydrochloride) capsuleprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-271165900843
314e4d8017-9c1d-41eb-affb-8046e3548be9 (view SPL)FLUOXETINE CAPSULES USPRx only4356prescriptionHuman PrescriptionContract Pharmacy Services-Pa2010-04-051670460211
324e81573a-ea76-47f8-897e-0e1d98550e46 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-06-261165900099
334e9158fa-939c-4ec3-b605-52eb722e2fc7 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987xprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-091521250340
3453655048-40a3-45b2-9336-5616cfab68f0 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-021332610184
3559de2889-c3d3-4ebf-8826-13f30a3fa439 (view SPL)These highlights do not include all the information needed to use Fluoxetine Capsules safely and effectively. See full prescribing information for Fluoxetine Capsules. Fluoxetine Capsules for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationMANUFACTURE2010-11-181637390493, 637390494
365cfc7640-9fa4-4dec-a3b1-353eb8111852 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP.Fluoxetine Capsules, USP for Oral UseInitial U.S. Approval: 1987prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-063680840101, 680840605
375e47c25f-c865-470d-8ea3-b4f9ca2ba5ba (view SPL)These highlights do not include all the information needed to use FLUOXETINE safely and effectively. See full prescribing information for FLUOXETINE.Initial U.S. Approval: 1987prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-07-201430630216
385e814a91-4bb2-4c8d-bdb5-c64ce5babf07 (view SPL)These highlights do not include all the information needed to use Fluoxetine Capsules, USP. See full prescribing information for Fluoxetine Capsules, USP and Initial U.S. ApprovalprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, relabel, repack2011-11-093108499990886
3962c47df4-2c71-437e-b142-bc193f6277f0 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionMed-Health Pharma, Llcrepack2012-03-204511380093, 511380094, 511380095
4062e08a06-2f62-42aa-828f-5c2d1415657e (view SPL)FLUOXETINEprescriptionHuman PrescriptionDirect Rxrepack2015-10-271619190490
4165d1a53c-25cd-4ad0-b5bb-b6e278bd9644 (view SPL)Fluoxetine 20mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture2010-08-19356499990128
4266a8531a-2507-402c-8919-c666ec3024c1 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-201493490518
436b8ebc39-da88-4491-bbf0-9be758c2ddfc (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. Fluoxetine capsules, USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionUnit Dose ServicesREPACK2013-02-062504360923
446bc0214b-b6f9-463d-a689-a93e59512b60 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Initial U.S. Approval: 1987prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-182548684537, 548684562
456ec00661-d82c-410e-9eae-94f4642506e5 (view SPL)These highlights do not include all the information needed to use Fluoxetine Capsules safely and effectively. See full prescribing information for Fluoxetine Capsules.Fluoxetine Capsules for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionBluepoint LaboratoriesMANUFACTURE2015-06-084680010129
466f4e4e9f-9ded-452f-b3ef-ab6aa9c72952 (view SPL)These highlights do not include all the information needed to use FLUOXETINE safely and effectively. See full prescribing information for FLUOXETINE. FLUOXETINE (FLUOXETINE) CAPSULE for ORAL use.Initial U.S. Approval: 2012prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2014-02-118231550028, 231550029, 231550030
4770c1c88a-672e-4865-a556-69b1d30752f0 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionUnit Dose ServicesREPACK2013-02-072504360924
4870e115cc-6e9b-4b96-a1a9-779ed51ad0a7 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE Capsules, USP for Oral UseInitial U.S. Approval: 1987prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-304631870069, 631870081
497125a96a-0e98-4984-8b57-a2e7a99b7b0d (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionMedvantx, Inc.REPACK2012-03-201661160453
5079dc6790-d679-4e6e-9e3f-7de8e88d4837 (view SPL)FLUOXETINE HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-022619190099
517cc62309-cb23-4888-afba-bb774658a748 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Initial U.S. Approval: 1987prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-09-111538080836
527d7a196b-91de-4753-8bb6-c6d5c668952d (view SPL)These highlights do not include all the information needed to use fluoxetine capsules safely and effectively. See full prescribing information for fluoxetine capsules. FLUOXETINE capsules, USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-12-0517430630570
537e82dcaa-fc75-4ea2-9465-5327e2747720 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-06-131422540235
54821b8070-9f6c-4810-8eed-d42a31627d3b (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-06-053978353560728
5583abe673-87ee-4a79-a49e-2c72576735c2 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP.FLUOXETINE Capsules, USP for Oral UseInitial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2014-11-061493490483
568609ed02-0b30-4c82-bab1-4d51d92ec224 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Fluoxetine capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionContract Pharmacy Services-Pa2010-07-301670460210
57894ece20-b681-4b7b-a452-113844594b31 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-04-161762370276
588953d343-d137-4ca5-a73f-3ceff1505b55 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Fluoxetine capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-07-191165900100
598c31b73f-9208-4507-afb1-fee9b1fe4711 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987xprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-181242360583
60930a8a8c-a81a-4110-bb2e-c87e531cbd83 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine capsules safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2012-02-176551110147, 551110148, 551110149
619914757b-5ef9-476e-9d0d-8da9ae53541e (view SPL)These highlights do not include all the information needed to use Fluoxetine Capsules USP safely and effectively. See full prescribing information for Fluoxetine Capsules, USP. Initial U.S. Approval: 1987prescriptionHuman PrescriptionCarlsbad Technology, Inc.analysis, manufacture2015-07-155614420151, 614420152
629ab14775-86b8-4a84-bec5-007dd29f3101 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Initial U.S. Approval: 1987prescriptionHuman PrescriptionCardinal HealthREPACK2012-07-252551545495
639e1353d7-83d1-4522-9352-5545db044a50 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE Capsules, USP for Oral UseInitial U.S. Approval: 1987prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-11-243687889222
64a1575590-4bdd-4f66-91fb-337e5f681747 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-271216950052, 216950053
65a2d6beb9-bec4-4623-bcc9-7f1bfddb9f0b (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionContract Pharmacy Services-Pa2011-05-161670460212
66a63876a5-2715-4399-8237-7ee68d07704b (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-09-111538080837
67a74b5d70-d673-459f-a202-2b29b85cc851 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionCardinal HealthREPACK2015-08-146551541341, 551546890
68a83f15dd-4e8a-4f00-a276-c39beade99c7 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP.Fluoxetine Capsules, USP for Oral UseInitial U.S. Approval: 1987prescriptionHuman PrescriptionCardinal HealthREPACK2015-05-071551547127
69ac0fe5db-e89e-4de7-9bba-15c966776f2a (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fluoxetine safely and effectively. See full prescribing information for Fluoxetine. Fluoxetine Capsules, USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2013-02-266498840872
70aca0b44e-598d-490b-87f4-f6701d1aad9e (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionLegacy Pharmaceutical Packaging, LlcRELABEL, REPACK2011-04-272686450131
71b050b0ee-107c-4f82-8031-92ec68baa6a2 (view SPL)These highlights do not include all the information needed to use Fluoxetine Capsules safely and effectively. See full prescribing information for Fluoxetine Capsules.Fluoxetine Capsules for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionNorthstar Rx LlcMANUFACTURE2015-06-0923167140351, 167140352, 167140353
72b07f9eab-44ac-4667-bd46-52d736daa5d6 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionLegacy Pharmaceutical Packaging, LlcRELABEL, REPACK2011-04-141686450130
73b3230c81-2a58-4033-848b-194dd2439843 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2010-12-21162493490479
74b4f37ef1-8f5e-4318-90f1-2d8f8afb669c (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE capsules, USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionVensun Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2015-07-211425430725, 425430726, 425430727
75b70f4505-ff39-4990-bb12-f9c4c1e3510c (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE Capsules, USP for Oral UseInitial U.S. Approval: 1987prescriptionHuman PrescriptionReadymedsrepack2014-05-0615642050193
76bb06af33-8ff7-0b02-0029-d628f62e1382 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-183636291610
77bb77d8a1-7c32-4f85-bdd2-a0093ec73e05 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.FLUOXETINE CAPSULES USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionCardinal HealthREPACK2014-10-291551544846
78befdb67d-62e6-4f40-9183-30b6e0718c53 (view SPL)These highlights do not include all the information needed to use FLUOXETINE capsules USP safely and effectively. See full prescribing information for FLUOXETINE capsules USP. Fluoxetine capsules USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-04-301001790060
79bfd18a45-06cc-4281-b181-40eb5d192a9b (view SPL)These highlights do not include all the information needed to use FLUOXETINE capsules, USP safely and effectively. See full prescribing information for FLUOXETINE capsules, USP. FLUOXETINE capsules, USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.api manufacture, manufacture, pack2014-03-116633040632
80c06f80cf-be99-0b77-ebd7-7a5f1561d4b4 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-06-245003785410, 003785420
81c0e3e84e-2c4e-45d9-b2e2-7c4d208eca67 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987xprescriptionHuman PrescriptionMedvantx, Inc.REPACK2013-03-081661160467
82c3edb2c8-acff-47f6-aa8a-21a07287cd76 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-05-2919000934346
83c44bceb0-568d-4199-a2b5-26668bc77474 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine capsules safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-02-177552890613
84c509f682-d68e-490a-884d-c067e4c23a5b (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionBarr Laboratories Inc.2013-09-137005550877
85c5ae25a0-aee4-4ac6-b631-83d45cefcd73 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine capsules safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-031521250342
86c85063c1-3a0a-4f50-b898-5afd3bd82fbb (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2014-08-044647250192, 647250193
87c88f33ed-6dfb-4c5e-bc01-d8e36dd97299 (view SPL)These highlights do not include all the information needed to use PROZAC safely and effectively. See full prescribing information for PROZAC. PROZAC (fluoxetine capsules) for oral usePROZAC (fluoxetine delayed-release capsules) for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionDista Products Company2015-02-0439007773104, 007773105, 007773107
88cb66a702-7670-4a73-98fb-0e63151a1ffb (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-05-211516550100
89cfdfd696-3185-48bb-ac50-f4a2ed512991 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. Fluoxetine capsules, USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionClinical Solutions Wholesalerelabel, repack2013-08-123581180632
90d31c9625-30c8-4efd-a31f-13930705d573 (view SPL)These highlights do not include all the information needed to use FLUOXETINE safely and effectively. See full prescribing information for FLUOXETINE.Initial U.S. Approval: 1987prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-10-1315552890610
91d534867a-e4ef-46ce-b61d-857387ce450a (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules. Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987prescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-03-142504360922
92db1c840d-ab22-4a4c-9ced-ae82c869dd9b (view SPL)These highlights do not include all the information needed to use FLUOXETINE CAPSULES USP safely and effectively. See full prescribing information for FLUOXETINE CAPSULES USP.FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionSandoz Inc2014-08-3117007812822, 007812823, 007812824
93e07fa54e-f4ee-496d-a7e9-533c85564be1 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules, USPsafely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE Capsules, USP for Oral UseInitial U.S. Approval: 1987prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-11-243687889223
94e1171b54-c1a3-4220-bc8a-92f49f270183 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-182548685663
95e3e8aa9d-9daf-4565-85c9-a8d79c46128b (view SPL)These highlights do not include all the information needed to use FLUOXETINE capsules, USP safely and effectively. See full prescribing information for FLUOXETINE capsules, USP. FLUOXETINE capsules, USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-06-062631870089
96e5336cf0-04c9-45f2-b364-5d9132726c52 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP.Initial U.S. Approval: 1987prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-04-092425490599
97e6c2595a-1470-4cf4-93ea-0fedf917cf85 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine. Initial U.S. Approval: 1987prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-281216950054
98e9d6c462-84af-4371-bc05-78cb0bcb589d (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Fluoxetine capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2010-10-052006151357
99ea1c989b-3395-4e68-a300-f0f042969c4f (view SPL)FLUOXETINEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-04-294619190100
100eb231077-fa47-4469-b3c5-4e13d2365252 (view SPL)These highlights do not include all the information needed to use FLUOXETINE capsules, USP safely and effectively. See full prescribing information for FLUOXETINE capsules, USP. FLUOXETINE capsules, USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-021332610883
101f1a9e2fc-f75a-46a6-82f1-c11fa0b281a2 (view SPL)These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. FLUOXETINE capsules USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionMedvantx, Inc.REPACK2013-08-151661160464
102f719162f-cb78-487c-b172-ac10d009e6f5 (view SPL)These highlights do not include all the information needed to use Fluoxetine safely and effectively. See full prescribing information for Fluoxetine. Fluoxetine capsules for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionProdigy Health Suppliermanufacture2012-03-011763650101, 763650102
103f7994951-93d4-42cb-88f5-b8ad8e9f5037 (view SPL)These highlights do not include all the information needed to use FLUOXETINE safely and effectively. See full prescribing information for FLUOXETINE. Initial U.S. Approval: 1987prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-011538080366

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII