Fluoxetine Oral Tablet

Brand(s)
Sarafem
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Warner Chilcott (Us), Llc (2014-10-31)
Oldest Current Product
2001-08-02
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\FLUOXETINE
FDAOB
ORAL\CAPSULE\FLUOXETINE HYDROCHLORIDE
ORAL\TABLET\FLUOXETINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\FLUOXETINE HYDROCHLORIDE
ORAL\TABLET\FLUOXETINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\FLUOXETINE
ORAL\TABLET\FLUOXETINE

product(s) by strength(s)

fluoxetine 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004300210SarafemNDAWarner Chilcott (Us), Llc2008-06-24FLUOXETINE HYDROCHLORIDEORALTABLETNDA021860e542de29-b400-4b2e-9d5e-0f7c53091f8c

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937188ANDATeva Pharmaceuticals Usa Inc2002-01-30FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075872662f3e16-bf42-4127-8e56-4eb45780e059
2003780734ANDAMylan Pharmaceuticals Inc.2013-12-23FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075755de336c75-566f-4083-a31b-842bad668b6e
3498840734ANDAPar Pharmaceutical Companies, Inc.2001-08-022016-11-30FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA07575550c8f400-8704-45bf-a7c7-696b5d54fefc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006155501ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2010-01-13FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATED498840734ANDA0757559b73e222-bb58-49b4-a27a-484738d42ba6
2216950320ANDARebel Distributors Corp2010-01-13FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATED498840734ANDA07575510a49211-025b-4d63-b60c-fadfd9b731c0
3353560649ANDALake Erie Medical Dba Quality Care Products Llc2010-01-13FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATED498840734ANDA07575509120812-5cd3-46b3-ad2f-4712df57f8d0
4422910278ANDAAvkare, Inc.2012-08-30FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATED498840734ANDA0757553b9d9f3a-f5c9-4fd1-78a4-9758df1dc62a
5538080988ANDAState Of Florida Doh Central Pharmacy2009-07-01FLUOXETINE HYDROCHLORIDEORALTABLET658620192ANDA07504988989ab9-8143-404d-8488-67a289e525b4
6548684560ANDAPhysicians Total Care, Inc.2003-08-19FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATED498840734ANDA075755d82283c9-57b9-483e-8de4-a92cac6d263f
7631870218ANDAProficient Rx Lp2002-01-30FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATED000937188ANDA075872d7144d7f-9d54-4fb0-a78e-c99a2e09987b

fluoxetine 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004300220SarafemNDAWarner Chilcott (Us), Llc2008-06-24FLUOXETINE HYDROCHLORIDEORALTABLETNDA021860e542de29-b400-4b2e-9d5e-0f7c53091f8c

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1003780735ANDAMylan Pharmaceuticals Inc.2013-12-23FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA075755de336c75-566f-4083-a31b-842bad668b6e
2498840735ANDAPar Pharmaceutical Companies, Inc.2001-08-022016-12-31FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA07575550c8f400-8704-45bf-a7c7-696b5d54fefc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006155502ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2010-01-13FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATED498840735ANDA0757559b73e222-bb58-49b4-a27a-484738d42ba6
2216950321ANDARebel Distributors Corp2010-01-13FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATED498840735ANDA07575510a49211-025b-4d63-b60c-fadfd9b731c0
3422910279ANDAAvkare, Inc.2012-08-30FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATED498840735ANDA0757553b9d9f3a-f5c9-4fd1-78a4-9758df1dc62a
4538080986ANDAState Of Florida Doh Central Pharmacy2009-07-01FLUOXETINE HYDROCHLORIDEORALTABLET658620193ANDA07504988989ab9-8143-404d-8488-67a289e525b4

fluoxetine 60 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1499090005NDAEdgemont Pharmaceuticals, Llc2011-11-14FLUOXETINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA202133abccfe74-aaf9-4729-a196-2d666f9562b5

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drugin other drug docs
1ANDA074803FLUOXETINE HYDROCHLORIDEBARR LABORATORIES INC2001-08-02ANDA074803_001, ANDA074803_002Fluoxetine Oral Capsule
2ANDA075049FLUOXETINE HYDROCHLORIDESANDOZ INC2001-08-02ANDA075049_001, ANDA075049_002, ANDA075049_003Fluoxetine Oral Capsule
3ANDA075207FLUOXETINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2002-01-30ANDA075207_001, ANDA075207_002, ANDA075207_003Fluoxetine Oral Capsule
4ANDA075245FLUOXETINE HYDROCHLORIDEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2002-01-31ANDA075245_001, ANDA075245_002, ANDA075245_003Fluoxetine Oral Capsule
5ANDA075452FLUOXETINE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2002-01-29ANDA075452_001, ANDA075452_002, ANDA075452_003Fluoxetine Oral Capsule
6ANDA075464FLUOXETINE HYDROCHLORIDELANDELA PHARMACEUTICAL2002-01-30ANDA075464_001, ANDA075464_002Fluoxetine Oral Capsule
7ANDA075465FLUOXETINE HYDROCHLORIDEDR REDDYS LABORATORIES LTD2001-08-02ANDA075465_001, ANDA075465_002, ANDA075465_003Fluoxetine Oral Capsule
8ANDA075577FLUOXETINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2002-01-29ANDA075577_001, ANDA075577_002Fluoxetine Oral Capsule
9ANDA075658FLUOXETINE HYDROCHLORIDEMALLINCKRODT INC2002-01-29ANDA075658_001, ANDA075658_002Fluoxetine Oral Capsule
10ANDA075662FLUOXETINETrueWATSON LABORATORIES INC2002-01-29ANDA075662_001, ANDA075662_002Fluoxetine Oral Capsule
11ANDA075755FLUOXETINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2001-08-02ANDA075755_001, ANDA075755_002
12ANDA075787FLUOXETINETrueMUTUAL PHARMACAL CO2002-01-29ANDA075787_001, ANDA075787_002Fluoxetine Oral Capsule
13ANDA075807FLUOXETINE HYDROCHLORIDETrueSANDOZ INC2002-01-29ANDA075807_001, ANDA075807_002Fluoxetine Oral Capsule
14ANDA075810FLUOXETINE HYDROCHLORIDETrueBARR LABORATORIES INC2002-02-01ANDA075810_001
15ANDA075865FLUOXETINE HYDROCHLORIDETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2002-02-28ANDA075865_001, ANDA075865_003
16ANDA075872FLUOXETINE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2002-01-29ANDA075872_001
17ANDA076001FLUOXETINE HYDROCHLORIDETEVA PHARMACEUTICALS USA2002-01-29ANDA076001_001, ANDA076001_002Fluoxetine Oral Capsule
18ANDA076006FLUOXETINE HYDROCHLORIDEDR REDDYS LABORATORIES INC2002-01-30ANDA076006_001
19ANDA076022FLUOXETINE HYDROCHLORIDETrueCARLSBAD TECHNOLOGY INC2002-01-30ANDA076022_001, ANDA076022_002Fluoxetine Oral Capsule
20ANDA076024FLUOXETINE HYDROCHLORIDETrueSANDOZ INC2002-01-29ANDA076024_001
21ANDA076165FLUOXETINE HYDROCHLORIDETrueCHINA RESOURCES DOUBLE CRANE PHARMACEUTICAL CO LTD2002-02-01ANDA076165_001, ANDA076165_002Fluoxetine Oral Capsule
22ANDA076251FLUOXETINE HYDROCHLORIDETrueBARR LABORATORIES INC2005-05-18ANDA076251_001Fluoxetine Oral Capsule
23ANDA076287FLUOXETINE HYDROCHLORIDETrueANI PHARMACEUTICALS INC2008-05-20ANDA076287_001, ANDA076287_002Fluoxetine Oral Capsule
24ANDA076922FLUOXETINE HYDROCHLORIDEPAR PHARMACEUTICAL INC2004-12-16ANDA076922_001, ANDA076922_002, ANDA076922_003Fluoxetine Oral Capsule
25ANDA076990FLUOXETINE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES LTD2004-12-13ANDA076990_001Fluoxetine Oral Capsule
26ANDA077469FLUOXETINE HYDROCHLORIDETrueSANDOZ INC2008-11-17ANDA077469_001, ANDA077469_002Fluoxetine Oral Capsule
27ANDA078045FLUOXETINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2008-11-17ANDA078045_001, ANDA078045_002Fluoxetine Oral Capsule
28ANDA078143FLUOXETINE HYDROCHLORIDETrueWOCKHARDT LTD2008-01-16ANDA078143_001, ANDA078143_002, ANDA078143_003Fluoxetine Oral Capsule
29ANDA078619FLUOXETINE HYDROCHLORIDEAUROBINDO PHARMA LTD2008-01-31ANDA078619_001, ANDA078619_002, ANDA078619_003Fluoxetine Oral Capsule
30ANDA090223FLUOXETINE HYDROCHLORIDEALEMBIC PHARMACEUTICALS LTD2009-03-19ANDA090223_001, ANDA090223_002, ANDA090223_003Fluoxetine Oral Capsule
31ANDA200151SELFEMRATEVA PHARMACEUTICALS USA INC2014-02-03ANDA200151_001, ANDA200151_002, ANDA200151_003
32ANDA201336FLUOXETINE HYDROCHLORIDEHERITAGE PHARMACEUTICALS INC2012-10-01ANDA201336_001, ANDA201336_002, ANDA201336_003Fluoxetine Oral Capsule
33ANDA204597FLUOXETINE HYDROCHLORIDESCIEGEN PHARMACEUTICALS INC2015-03-16ANDA204597_001, ANDA204597_002, ANDA204597_003Fluoxetine Oral Capsule
34NDA018936PROZACELI 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 Capsule
35NDA020974PROZACTrueELI LILLY AND CO1999-03-09NDA020974_001, NDA020974_002
36NDA021860SARAFEMWARNER CHILCOTT CO LLC2006-05-19NDA021860_001, NDA021860_002, NDA021860_003
37NDA202133FLUOXETINE HYDROCHLORIDEEDGEMONT PHARMACEUTICALS LLC2011-10-06NDA202133_001

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
26ANDA075755_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalseAB2001-08-02FLUOXETINE HYDROCHLORIDE
27ANDA075755_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALTABLETTrue2001-08-02FLUOXETINE HYDROCHLORIDE
28ANDA075787_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE
29ANDA075787_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE
30ANDA075807_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE HYDROCHLORIDE
31ANDA075807_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2002-01-29FLUOXETINE HYDROCHLORIDE
32ANDA075810_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalse2002-02-01FLUOXETINE HYDROCHLORIDE
33ANDA075865_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalse2002-02-28FLUOXETINE HYDROCHLORIDE
34ANDA075865_003discontinuedFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALTABLETFalse2004-08-30FLUOXETINE HYDROCHLORIDE
35ANDA075872_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalseAB2002-01-29FLUOXETINE HYDROCHLORIDE
36ANDA076001_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
37ANDA076001_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12002-01-29FLUOXETINE HYDROCHLORIDE
38ANDA076006_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalseAB2002-01-30FLUOXETINE HYDROCHLORIDE
39ANDA076022_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2002-01-30FLUOXETINE HYDROCHLORIDE
40ANDA076022_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2002-01-30FLUOXETINE HYDROCHLORIDE
41ANDA076024_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalse2002-01-29FLUOXETINE HYDROCHLORIDE
42ANDA076165_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2002-02-01FLUOXETINE HYDROCHLORIDE
43ANDA076165_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2002-02-01FLUOXETINE HYDROCHLORIDE
44ANDA076251_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalse2005-05-18FLUOXETINE HYDROCHLORIDE
45ANDA076287_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2008-05-20FLUOXETINE HYDROCHLORIDE
46ANDA076287_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2008-05-20FLUOXETINE HYDROCHLORIDE
47ANDA076922_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2004-12-16FLUOXETINE HYDROCHLORIDE
48ANDA076922_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2004-12-16FLUOXETINE HYDROCHLORIDE
49ANDA076922_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2004-12-16FLUOXETINE HYDROCHLORIDE
50ANDA076990_001RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2004-12-13FLUOXETINE HYDROCHLORIDE
51ANDA077469_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2008-11-17FLUOXETINE HYDROCHLORIDE
52ANDA077469_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2008-11-17FLUOXETINE HYDROCHLORIDE
53ANDA078045_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB22008-11-17FLUOXETINE HYDROCHLORIDE
54ANDA078045_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULETrue2008-11-17FLUOXETINE HYDROCHLORIDE
55ANDA078143_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2008-01-16FLUOXETINE HYDROCHLORIDE
56ANDA078143_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2008-01-16FLUOXETINE HYDROCHLORIDE
57ANDA078143_003discontinuedFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalse2008-01-16FLUOXETINE HYDROCHLORIDE
58ANDA078619_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12008-01-31FLUOXETINE HYDROCHLORIDE
59ANDA078619_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12008-01-31FLUOXETINE HYDROCHLORIDE
60ANDA078619_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2008-01-31FLUOXETINE HYDROCHLORIDE
61ANDA090223_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12009-03-19FLUOXETINE HYDROCHLORIDE
62ANDA090223_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12009-03-19FLUOXETINE HYDROCHLORIDE
63ANDA090223_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2009-03-19FLUOXETINE HYDROCHLORIDE
64ANDA200151_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalseAB12014-02-03SELFEMRA
65ANDA200151_002RXFLUOXETINE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB12014-02-03SELFEMRA
66ANDA200151_003RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALTABLETFalseAB12014-02-03SELFEMRA
67ANDA201336_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12012-10-01FLUOXETINE HYDROCHLORIDE
68ANDA201336_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12012-10-01FLUOXETINE HYDROCHLORIDE
69ANDA201336_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2012-10-01FLUOXETINE HYDROCHLORIDE
70ANDA204597_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB12015-03-16FLUOXETINE HYDROCHLORIDE
71ANDA204597_002RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB12015-03-16FLUOXETINE HYDROCHLORIDE
72ANDA204597_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULEFalseAB2015-03-16FLUOXETINE HYDROCHLORIDE
73NDA018936_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalseAB11987-12-29PROZAC
74NDA018936_003RXFLUOXETINE HYDROCHLORIDE (EQ 40MG BASE)ORALCAPSULETrueAB1999-06-15PROZAC
75NDA018936_004discontinuedFLUOXETINE HYDROCHLORIDE (EQ 60MG BASE)ORALCAPSULEFalse1999-06-15PROZAC
76NDA018936_006RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalseAB11992-12-23PROZAC
77NDA018936_007discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALCAPSULEFalse2000-07-06PROZAC
78NDA018936_008discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALCAPSULEFalse2000-07-06PROZAC
79NDA020974_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalse1999-03-09PROZAC
80NDA020974_002discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALTABLETFalse1999-03-09PROZAC
81NDA021860_001RXFLUOXETINE HYDROCHLORIDE (EQ 10MG BASE)ORALTABLETFalseAB12006-05-19SARAFEM
82NDA021860_002RXFLUOXETINE HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalseAB12006-05-19SARAFEM
83NDA021860_003RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE)ORALTABLETTrueAB12006-05-19SARAFEM
84NDA202133_001RXFLUOXETINE HYDROCHLORIDE (EQ 60MG BASE)ORALTABLETFalse2011-10-06FLUOXETINE HYDROCHLORIDE

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
109120812-5cd3-46b3-ad2f-4712df57f8d0 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2014-05-203816353560649
210a49211-025b-4d63-b60c-fadfd9b731c0 (view SPL)FluoxetineprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-281216950320, 216950321
33b9d9f3a-f5c9-4fd1-78a4-9758df1dc62a (view SPL)prescriptionHuman PrescriptionAvkare, Inc.2012-08-301422910278, 422910279
450c8f400-8704-45bf-a7c7-696b5d54fefc (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.ANALYSIS, MANUFACTURE2015-01-093498840734, 498840735
5662f3e16-bf42-4127-8e56-4eb45780e059 (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 tablets USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-06-129000937188
688989ab9-8143-404d-8488-67a289e525b4 (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 Pharmacyrepack2010-06-011538080986, 538080988
79b73e222-bb58-49b4-a27a-484738d42ba6 (view SPL)FLUOXETINE TABLETS USP Rx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-04-0915006155501, 006155502
8abccfe74-aaf9-4729-a196-2d666f9562b5 (view SPL)These highlights do not include all the information needed to use FLUOXETINE safely and effectively. See full prescribing information for FLUOXETINE. FLUOXETINE tablets for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionEdgemont Pharmaceuticals, LlcLABEL, MANUFACTURE, PACK2014-09-165499090005
9d7144d7f-9d54-4fb0-a78e-c99a2e09987b (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 tablets USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-09-011631870218
10d82283c9-57b9-483e-8de4-a92cac6d263f (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-02-121548684560
11de336c75-566f-4083-a31b-842bad668b6e (view SPL)These highlights do not include all the information needed to use fluoxetine tablets safely and effectively. See full prescribing information for fluoxetine tablets.FLUOXETINE tablets, USP for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-11-255003780734, 003780735
12e542de29-b400-4b2e-9d5e-0f7c53091f8c (view SPL)These highlights do not include all the information needed to use SARAFEM safely and effectively. See full prescribing information for SARAFEM.SARAFEM (fluoxetine hydrochloride tablets) for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionWarner Chilcott (Us), Llc2014-10-315004300210, 004300220, 004300215

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