Fluvoxamine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eon Labs, Inc. (2014-11-12)
Oldest Current Product
2000-11-29
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\FLUVOXAMINE
FDAOB
ORAL\TABLET\FLUVOXAMINE MALEATE
SPL Active
ORAL\TABLET, COATED\FLUVOXAMINE MALEATE
ORAL\TABLET, FILM COATED\FLUVOXAMINE MALEATE
ORAL\TABLET\FLUVOXAMINE MALEATE
SPL Moiety
ORAL\TABLET, COATED\FLUVOXAMINE
ORAL\TABLET, FILM COATED\FLUVOXAMINE
ORAL\TABLET\FLUVOXAMINE

product(s) by strength(s)

fluvoxamine maleate 100 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850157ANDAEon Labs, Inc.2000-11-29FLUVOXAMINE MALEATEORALTABLET, FILM COATEDANDA0758886ffd38bc-0fa1-4ed5-8391-98487b7823d4
2003780414ANDAMylan Pharmaceuticals Inc.2000-12-20FLUVOXAMINE MALEATEORALTABLET, FILM COATEDANDA07588953664f8d-3a93-9f2b-daee-380707e4062c
3510790993ANDAMylan Institutional Inc.2002-09-15FLUVOXAMINE MALEATEORALTABLET, FILM COATEDANDA075889d579b480-0e49-461c-b784-a51a5272849f
4605050166ANDAApotex Corp2001-07-10FLUVOXAMINE MALEATEORALTABLETANDA0759026eeb14df-6fcf-a737-5359-5744eb4accea
5625590160NDA AUTHORIZED GENERICAnip Acquisition Company2011-08-09FLUVOXAMINE MALEATEORALTABLET, COATEDNDA0215197ecd83ec-88f5-4f85-9cc2-9068375d8820

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1576640362ANDACaraco Pharmaceutical Laboratories, Ltd.2006-02-23FLUVOXAMINE MALEATEORALTABLETANDA0759004fa83401-321d-4fb9-bd7f-8cfa966782e3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157569ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2010-03-12FLUVOXAMINE MALEATEORALTABLET, FILM COATED000930057ANDA075893727a5eb4-ac82-444d-8381-44c34ee3b895
2493490655NDARemedyrepack Inc.2013-09-11FLUVOXAMINE MALEATEORALTABLET427691221NDA021519436b4614-76b3-4335-a631-116f67f4b3b6
3604290760ANDAGolden State Medical Supply, Inc.2001-05-07FLUVOXAMINE MALEATEORALTABLET605050166ANDA0759024b1e7c09-c393-4f1e-be68-8a662ceda185
4636294125ANDABryant Ranch Prepack2010-03-12FLUVOXAMINE MALEATEORALTABLET, FILM COATED005550969ANDA075897d9b3e380-734b-5b0d-f8cb-e50172910c99

fluvoxamine maleate 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850017ANDAEon Labs, Inc.2000-11-29FLUVOXAMINE MALEATEORALTABLET, FILM COATEDANDA0758886ffd38bc-0fa1-4ed5-8391-98487b7823d4
2003780407ANDAMylan Pharmaceuticals Inc.2000-12-20FLUVOXAMINE MALEATEORALTABLET, FILM COATEDANDA07588953664f8d-3a93-9f2b-daee-380707e4062c
3605050164ANDAApotex Corp2001-07-10FLUVOXAMINE MALEATEORALTABLETANDA0759026eeb14df-6fcf-a737-5359-5744eb4accea
4625590158NDA AUTHORIZED GENERICAnip Acquisition Company2011-08-09FLUVOXAMINE MALEATEORALTABLET, COATEDNDA0215197ecd83ec-88f5-4f85-9cc2-9068375d8820

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900270NDAStat Rx Usa Llc2008-04-14FLUVOXAMINE MALEATEORALTABLET427691222NDA0222358f0ff905-5eb3-4ad0-ad31-fe35b924211f
2576640357ANDACaraco Pharmaceutical Laboratories, Ltd.2006-02-23FLUVOXAMINE MALEATEORALTABLETANDA0759004fa83401-321d-4fb9-bd7f-8cfa966782e3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290758ANDAGolden State Medical Supply, Inc.2001-05-07FLUVOXAMINE MALEATEORALTABLET605050164ANDA0759024b1e7c09-c393-4f1e-be68-8a662ceda185

fluvoxamine maleate 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850027ANDAEon Labs, Inc.2000-11-29FLUVOXAMINE MALEATEORALTABLET, FILM COATEDANDA0758886ffd38bc-0fa1-4ed5-8391-98487b7823d4
2003780412ANDAMylan Pharmaceuticals Inc.2000-12-20FLUVOXAMINE MALEATEORALTABLET, FILM COATEDANDA07588953664f8d-3a93-9f2b-daee-380707e4062c
3510790992ANDAMylan Institutional Inc.2002-09-15FLUVOXAMINE MALEATEORALTABLET, FILM COATEDANDA075889d579b480-0e49-461c-b784-a51a5272849f
4605050165ANDAApotex Corp2001-07-10FLUVOXAMINE MALEATEORALTABLETANDA0759026eeb14df-6fcf-a737-5359-5744eb4accea
5625590159NDA AUTHORIZED GENERICAnip Acquisition Company2011-08-09FLUVOXAMINE MALEATEORALTABLET, COATEDNDA0215197ecd83ec-88f5-4f85-9cc2-9068375d8820

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1576640361ANDACaraco Pharmaceutical Laboratories, Ltd.2006-02-23FLUVOXAMINE MALEATEORALTABLETANDA0759004fa83401-321d-4fb9-bd7f-8cfa966782e3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1332610683NDA AUTHORIZED GENERICAidarex Pharmaceuticals Llc2011-08-09FLUVOXAMINE MALEATEORALTABLET, COATED625590159NDA021519ee2aa73e-7b14-4d64-94a7-d843e08d5d77
2493490828ANDARemedyrepack Inc.2011-11-30FLUVOXAMINE MALEATEORALTABLET005550968ANDA0758934d80812c-dfc1-456c-9368-697267630c2c
3604290759ANDAGolden State Medical Supply, Inc.2001-05-07FLUVOXAMINE MALEATEORALTABLET605050165ANDA0759024b1e7c09-c393-4f1e-be68-8a662ceda185
4636294676ANDABryant Ranch Prepack2000-11-29FLUVOXAMINE MALEATEORALTABLET, FILM COATED001850027ANDA075888bca3e46b-0966-4168-b570-11a9d9aea6d2
5680840837ANDAAmerican Health Packaging2014-09-29FLUVOXAMINE MALEATEORALTABLET605050165ANDA0759020b107225-ed5a-4461-9184-f3f2bad1892f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075887FLUVOXAMINE MALEATETrueSANDOZ INC2001-01-05ANDA075887_001, ANDA075887_002, ANDA075887_003
2ANDA075888FLUVOXAMINE MALEATESANDOZ INC2000-11-29ANDA075888_001, ANDA075888_002, ANDA075888_003
3ANDA075889FLUVOXAMINE MALEATEMYLAN PHARMACEUTICALS INC2000-11-29ANDA075889_001, ANDA075889_002, ANDA075889_003
4ANDA075893FLUVOXAMINE MALEATETEVA PHARMACEUTICALS USA INC2002-09-10ANDA075893_001, ANDA075893_002, ANDA075893_003
5ANDA075894FLUVOXAMINE MALEATETrueWATSON LABORATORIES INC2001-04-18ANDA075894_001, ANDA075894_002, ANDA075894_003
6ANDA075897FLUVOXAMINE MALEATEANI PHARMACEUTICALS INC2001-01-25ANDA075897_001, ANDA075897_002, ANDA075897_003
7ANDA075898FLUVOXAMINE MALEATETrueANI PHARMACEUTICALS INC2001-03-12ANDA075898_001, ANDA075898_002, ANDA075898_003
8ANDA075899FLUVOXAMINE MALEATETrueSYNTHON PHARMACEUTICALS LTD2001-01-17ANDA075899_001, ANDA075899_002, ANDA075899_003
9ANDA075900FLUVOXAMINE MALEATETrueSUN PHARMACEUTICAL INDUSTRIES INC2006-02-23ANDA075900_001, ANDA075900_002, ANDA075900_003
10ANDA075901FLUVOXAMINE MALEATETrueACTAVIS ELIZABETH LLC2000-12-28ANDA075901_001, ANDA075901_002, ANDA075901_003
11ANDA075902FLUVOXAMINE MALEATEAPOTEX INC2001-05-07ANDA075902_001, ANDA075902_002, ANDA075902_003
12ANDA075950FLUVOXAMINE MALEATETrueMYLAN PHARMACEUTICALS INC2001-10-15ANDA075950_001, ANDA075950_002
13ANDA076125FLUVOXAMINE MALEATETrueMUTUAL PHARMACEUTICAL CO INC2002-04-29ANDA076125_001, ANDA076125_002, ANDA076125_003
14NDA020243LUVOXTrueSOLVAY PHARMACEUTICALS1994-12-05NDA020243_001, NDA020243_002, NDA020243_003, NDA020243_004
15NDA021519LUVOXANI PHARMACEUTICALS INC2007-12-20NDA021519_001, NDA021519_002, NDA021519_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075887_001discontinuedFLUVOXAMINE MALEATE (25MG)ORALTABLETFalse2001-01-05FLUVOXAMINE MALEATE
2ANDA075887_002discontinuedFLUVOXAMINE MALEATE (50MG)ORALTABLETFalse2001-01-05FLUVOXAMINE MALEATE
3ANDA075887_003discontinuedFLUVOXAMINE MALEATE (100MG)ORALTABLETFalse2001-01-05FLUVOXAMINE MALEATE
4ANDA075888_001RXFLUVOXAMINE MALEATE (25MG)ORALTABLETFalseAB2000-11-29FLUVOXAMINE MALEATE
5ANDA075888_002RXFLUVOXAMINE MALEATE (50MG)ORALTABLETFalseAB2000-11-29FLUVOXAMINE MALEATE
6ANDA075888_003RXFLUVOXAMINE MALEATE (100MG)ORALTABLETTrueAB2000-11-29FLUVOXAMINE MALEATE
7ANDA075889_001RXFLUVOXAMINE MALEATE (25MG)ORALTABLETFalseAB2000-11-29FLUVOXAMINE MALEATE
8ANDA075889_002RXFLUVOXAMINE MALEATE (50MG)ORALTABLETFalseAB2000-11-29FLUVOXAMINE MALEATE
9ANDA075889_003RXFLUVOXAMINE MALEATE (100MG)ORALTABLETFalseAB2000-11-29FLUVOXAMINE MALEATE
10ANDA075893_001RXFLUVOXAMINE MALEATE (25MG)ORALTABLETFalseAB2002-09-10FLUVOXAMINE MALEATE
11ANDA075893_002RXFLUVOXAMINE MALEATE (50MG)ORALTABLETFalseAB2002-09-10FLUVOXAMINE MALEATE
12ANDA075893_003RXFLUVOXAMINE MALEATE (100MG)ORALTABLETFalseAB2002-09-10FLUVOXAMINE MALEATE
13ANDA075894_001discontinuedFLUVOXAMINE MALEATE (25MG)ORALTABLETFalse2001-04-18FLUVOXAMINE MALEATE
14ANDA075894_002discontinuedFLUVOXAMINE MALEATE (50MG)ORALTABLETFalse2001-04-18FLUVOXAMINE MALEATE
15ANDA075894_003discontinuedFLUVOXAMINE MALEATE (100MG)ORALTABLETFalse2001-04-18FLUVOXAMINE MALEATE
16ANDA075897_001RXFLUVOXAMINE MALEATE (25MG)ORALTABLETFalseAB2001-01-25FLUVOXAMINE MALEATE
17ANDA075897_002RXFLUVOXAMINE MALEATE (50MG)ORALTABLETFalseAB2001-01-25FLUVOXAMINE MALEATE
18ANDA075897_003RXFLUVOXAMINE MALEATE (100MG)ORALTABLETFalseAB2001-01-25FLUVOXAMINE MALEATE
19ANDA075898_001discontinuedFLUVOXAMINE MALEATE (25MG)ORALTABLETFalse2001-03-12FLUVOXAMINE MALEATE
20ANDA075898_002discontinuedFLUVOXAMINE MALEATE (50MG)ORALTABLETFalse2001-03-12FLUVOXAMINE MALEATE
21ANDA075898_003discontinuedFLUVOXAMINE MALEATE (100MG)ORALTABLETFalse2001-03-12FLUVOXAMINE MALEATE
22ANDA075899_001discontinuedFLUVOXAMINE MALEATE (25MG)ORALTABLETFalse2001-01-17FLUVOXAMINE MALEATE
23ANDA075899_002discontinuedFLUVOXAMINE MALEATE (50MG)ORALTABLETFalse2001-01-17FLUVOXAMINE MALEATE
24ANDA075899_003discontinuedFLUVOXAMINE MALEATE (100MG)ORALTABLETFalse2001-01-17FLUVOXAMINE MALEATE
25ANDA075900_001discontinuedFLUVOXAMINE MALEATE (25MG)ORALTABLETFalse2006-02-23FLUVOXAMINE MALEATE
26ANDA075900_002discontinuedFLUVOXAMINE MALEATE (50MG)ORALTABLETFalse2006-02-23FLUVOXAMINE MALEATE
27ANDA075900_003discontinuedFLUVOXAMINE MALEATE (100MG)ORALTABLETFalse2006-02-23FLUVOXAMINE MALEATE
28ANDA075901_001discontinuedFLUVOXAMINE MALEATE (25MG)ORALTABLETFalse2000-12-28FLUVOXAMINE MALEATE
29ANDA075901_002discontinuedFLUVOXAMINE MALEATE (50MG)ORALTABLETFalse2000-12-28FLUVOXAMINE MALEATE
30ANDA075901_003discontinuedFLUVOXAMINE MALEATE (100MG)ORALTABLETFalse2000-12-28FLUVOXAMINE MALEATE
31ANDA075902_001RXFLUVOXAMINE MALEATE (25MG)ORALTABLETFalseAB2001-05-07FLUVOXAMINE MALEATE
32ANDA075902_002RXFLUVOXAMINE MALEATE (50MG)ORALTABLETFalseAB2001-05-07FLUVOXAMINE MALEATE
33ANDA075902_003RXFLUVOXAMINE MALEATE (100MG)ORALTABLETFalseAB2001-05-07FLUVOXAMINE MALEATE
34ANDA075950_001discontinuedFLUVOXAMINE MALEATE (50MG)ORALTABLETFalse2001-10-15FLUVOXAMINE MALEATE
35ANDA075950_002discontinuedFLUVOXAMINE MALEATE (100MG)ORALTABLETFalse2001-10-15FLUVOXAMINE MALEATE
36ANDA076125_001discontinuedFLUVOXAMINE MALEATE (25MG)ORALTABLETFalse2002-04-29FLUVOXAMINE MALEATE
37ANDA076125_002discontinuedFLUVOXAMINE MALEATE (50MG)ORALTABLETFalse2002-04-29FLUVOXAMINE MALEATE
38ANDA076125_003discontinuedFLUVOXAMINE MALEATE (100MG)ORALTABLETFalse2002-04-29FLUVOXAMINE MALEATE
39NDA020243_001discontinuedFLUVOXAMINE MALEATE (25MG)ORALTABLETFalse1994-12-05LUVOX
40NDA020243_002discontinuedFLUVOXAMINE MALEATE (50MG)ORALTABLETFalse1994-12-05LUVOX
41NDA020243_003discontinuedFLUVOXAMINE MALEATE (100MG)ORALTABLETFalse1994-12-05LUVOX
42NDA020243_004discontinuedFLUVOXAMINE MALEATE (150MG)ORALTABLETFalse1994-12-05LUVOX
43NDA021519_001RXFLUVOXAMINE MALEATE (25MG)ORALTABLETFalseAB2007-12-20LUVOX
44NDA021519_002RXFLUVOXAMINE MALEATE (50MG)ORALTABLETFalseAB2007-12-20LUVOX
45NDA021519_003RXFLUVOXAMINE MALEATE (100MG)ORALTABLETFalseAB2007-12-20LUVOX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b107225-ed5a-4461-9184-f3f2bad1892f (view SPL)These highlights do not include all the information needed to use fluvoxamine maleate tablets, USP safely and effectively. See full prescribing information for fluvoxamine maleate tablets, USP. FLUVOXAMINE MALEATE Tablets, USP for oral administration Initial U.S. Approval: 1994prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-10-211680840837
2436b4614-76b3-4335-a631-116f67f4b3b6 (view SPL)Fluvoxamine Maleate TabletsThese highlights do not include all the information needed to use fluvoxamine maleate safely and effectively. See full prescribing information for Fluvoxamine Maleate Tablets.fluvoxamine maleate (Fluvoxamine maleate) Tablet, Coated for Oral use.Initial U.S. Approval: 1994prescriptionHuman PrescriptionRemedyrepack Inc.2013-09-111493490655
34b1e7c09-c393-4f1e-be68-8a662ceda185 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use nevirapine safely and effectively. See full prescribing information for nevirapine. Fluvoxamine Maleate, USP Tablets, 25mg, 50mg, 100mg Initial U.S. Approval: 2001prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290758, 604290759, 604290760
44d80812c-dfc1-456c-9368-697267630c2c (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-11-301493490828
54fa83401-321d-4fb9-bd7f-8cfa966782e3 (view SPL)These highlights do not include all the information needed to use Fluvoxamine Maleate Tablets safely and effectively. See full prescribing information for Fluvoxamine Maleate Tablets. Fluvoxamine Maleate Tablets, USP for oral administrationInitial U.S. Approval: 1994prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE2011-10-204576640357, 576640361, 576640362
653664f8d-3a93-9f2b-daee-380707e4062c (view SPL)These highlights do not include all the information needed to use fluvoxamine maleate tablets safely and effectively. See full prescribing information for fluvoxamine maleate tablets. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-12-088003780407, 003780412, 003780414
76eeb14df-6fcf-a737-5359-5744eb4accea (view SPL)These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS, USP safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS, USP. FLUVOXAMINE MALEATE tablets, for oral administration Initial U.S. Approval: 1994prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-08-316605050164, 605050165, 605050166
86ffd38bc-0fa1-4ed5-8391-98487b7823d4 (view SPL)These highlights do not include all the information needed to use Fluvoxamine Maleate Tablets USP safely and effectively. See full prescribing information for Fluvoxamine Maleate Tablets USP.Fluvoxamine Maleate Tablets USP for oral administrationInitial U.S. Approval: 1994prescriptionHuman PrescriptionEon Labs, Inc.2014-11-1220001850017, 001850027, 001850157
9727a5eb4-ac82-444d-8381-44c34ee3b895 (view SPL)These highlights do not include all the information needed to use fluvoxamine maleate tablets USP safely and effectively. See full prescribing information for fluvoxamine maleate tablets USP. Fluvoxamine maleate tablets USP, for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-03-044006157569
107ecd83ec-88f5-4f85-9cc2-9068375d8820 (view SPL)Fluvoxamine Maleate Tablets These highlights do not include all the information needed to use Fluvoxamine Maleate Tablets safely and effectively. See full prescribing information for Fluvoxamine Maleate Tablets. Fluvoxamine Maleate Tablets for oral administrationInitial U.S. Approval: 1994prescriptionHuman PrescriptionAnip Acquisition Company2015-05-265625590158, 625590159, 625590160
118f0ff905-5eb3-4ad0-ad31-fe35b924211f (view SPL)InsertprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-271165900270
12bca3e46b-0966-4168-b570-11a9d9aea6d2 (view SPL)These highlights do not include all the information needed to use Fluvoxamine Maleate Tablets USP safely and effectively. See full prescribing information for Fluvoxamine Maleate Tablets USP.Initial U.S. Approval: 1994prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636294676
13d579b480-0e49-461c-b784-a51a5272849f (view SPL)These highlights do not include all the information needed to use fluvoxamine maleate tablets safely and effectively. See full prescribing information for fluvoxamine maleate tablets.Fluvoxamine Maleate Tablet, film coated for oral administrationInitial U.S. Approval: 1994prescriptionHuman PrescriptionMylan Institutional Inc.2013-06-073510790992, 510790993
14d9b3e380-734b-5b0d-f8cb-e50172910c99 (view SPL)These highlights do not include all the information needed to use fluvoxamine maleate tablets safely and effectively. See full prescribing information for fluvoxamine maleate tablets. Fluvoxamine maleate tablets for oral administration Initial U.S. Approval: 1994prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636294125
15ee2aa73e-7b14-4d64-94a7-d843e08d5d77 (view SPL)Fluvoxamine Maleate Tablets These highlights do not include all the information needed to use Fluvoxamine Maleate Tablets safely and effectively. See full prescribing information for Fluvoxamine Maleate Tablets. Fluvoxamine Maleate Tablets for oral administrationInitial U.S. Approval: 1994prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-021332610683

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