Fluoxetine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmaceutical Associates, Inc. (2012-07-31)
Oldest Current Product
2001-08-02
License(s)
ANDA
RxNORM
ORAL SOLUTION\FLUOXETINE
FDAOB
ORAL\SOLUTION\FLUOXETINE HYDROCHLORIDE
SPL Active
ORAL\LIQUID\FLUOXETINE HYDROCHLORIDE
ORAL\SOLUTION\FLUOXETINE HYDROCHLORIDE
SPL Moiety
ORAL\LIQUID\FLUOXETINE
ORAL\SOLUTION\FLUOXETINE

product(s) by strength(s)

fluoxetine 4 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000936108ANDATeva Pharmaceuticals Usa Inc2001-08-02FLUOXETINE HYDROCHLORIDEORALSOLUTIONANDA075506f27ef79a-d212-4752-8300-b88b61d0464d
2001210721ANDAPharmaceutical Associates, Inc.2002-01-30FLUOXETINE HYDROCHLORIDEORALSOLUTIONANDA076015180a07fd-1f6a-4617-b8e0-f938c65ba273
3001214721ANDAPharmaceutical Associates, Inc.2002-02-01FLUOXETINE HYDROCHLORIDEORALSOLUTIONANDA076015180a07fd-1f6a-4617-b8e0-f938c65ba273
4548380523ANDASilarx Pharmaceuticals, Inc2009-08-27FLUOXETINE HYDROCHLORIDEORALLIQUIDANDA077849c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1
5604320162ANDAMorton Grove Pharmaceuticals, Inc.2002-08-29FLUOXETINE HYDROCHLORIDEORALSOLUTIONANDA075514142f9b27-65a7-4add-bdcc-2468695fedff
6658620306ANDAAurobindo Pharma Limited2009-03-19FLUOXETINE HYDROCHLORIDEORALSOLUTIONANDA0792093195db14-0cae-4b49-9fba-49b869fe92a8

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075292FLUOXETINE HYDROCHLORIDETrueAPOTEX INC2002-02-07ANDA075292_001
2ANDA075506FLUOXETINE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2001-08-02ANDA075506_001
3ANDA075514FLUOXETINE HYDROCHLORIDEWOCKHARDT EU OPERATIONS (SWISS) AG2002-08-29ANDA075514_001
4ANDA075525FLUOXETINE HYDROCHLORIDETrueHI TECH PHARMACAL CO INC2002-06-27ANDA075525_001
5ANDA075690FLUOXETINE HYDROCHLORIDETrueACTAVIS MID ATLANTIC LLC2002-01-31ANDA075690_001
6ANDA075920FLUOXETINE HYDROCHLORIDEMALLINCKRODT INC2002-01-29ANDA075920_001
7ANDA076015FLUOXETINE HYDROCHLORIDEPHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS2002-01-30ANDA076015_001
8ANDA076458FLUOXETINE HYDROCHLORIDELANNETT HOLDINGS INC2004-05-14ANDA076458_001
9ANDA077849FLUOXETINE HYDROCHLORIDESILARX PHARMACEUTICALS INC2007-02-09ANDA077849_001
10ANDA079209FLUOXETINE HYDROCHLORIDEAUROBINDO PHARMA USA INC2009-03-20ANDA079209_001
11NDA020101PROZACTrueELI LILLY AND CO1991-04-24NDA020101_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075292_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalse2002-02-07FLUOXETINE HYDROCHLORIDE
2ANDA075506_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalseAA2001-08-02FLUOXETINE HYDROCHLORIDE
3ANDA075514_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalseAA2002-08-29FLUOXETINE HYDROCHLORIDE
4ANDA075525_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalse2002-06-27FLUOXETINE HYDROCHLORIDE
5ANDA075690_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalse2002-01-31FLUOXETINE HYDROCHLORIDE
6ANDA075920_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalseAA2002-01-29FLUOXETINE HYDROCHLORIDE
7ANDA076015_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONTrueAA2002-01-30FLUOXETINE HYDROCHLORIDE
8ANDA076458_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalseAA2004-05-14FLUOXETINE HYDROCHLORIDE
9ANDA077849_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalseAA2007-02-09FLUOXETINE HYDROCHLORIDE
10ANDA079209_001RXFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalseAA2009-03-20FLUOXETINE HYDROCHLORIDE
11NDA020101_001discontinuedFLUOXETINE HYDROCHLORIDE (EQ 20MG BASE/5ML)ORALSOLUTIONFalse1991-04-24PROZAC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1142f9b27-65a7-4add-bdcc-2468695fedff (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for Fluoxetine Oral Solution USP.Fluoxetine oral solution for oral useInitial U.S. Approval: 1991prescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2015-03-047604320162
2180a07fd-1f6a-4617-b8e0-f938c65ba273 (view SPL)These highlights do not include all the information needed to use fluoxetine hydrochloride safely and effectively. See full prescribing information for Fluoxetine Oral Solution USP.Fluoxetine oral solution for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2012-07-313001210721, 001214721
33195db14-0cae-4b49-9fba-49b869fe92a8 (view SPL)These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine oral solution, USP. FLUOXETINE oral solution, USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-0212658620306
4c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine hydrochloride safely and effectively. See full prescribing information for Fluoxetine Oral Solution USP. Fluoxetine oral solution for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionSilarx Pharmaceuticals, Inc2014-06-2717548380523
5f27ef79a-d212-4752-8300-b88b61d0464d (view SPL)These highlights do not include all the information needed to use fluoxetine oral solution USP safely and effectively. See full prescribing information for fluoxetine oral solution USP. FLUOXETINE oral solution USP for oral useInitial U.S. Approval: 1987prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-09-0511000936108

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