← FDA DRUG APPROVALS

FDA ANDA · ANDA075245

FLUOXETINE HYDROCHLORIDE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA075245
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-31
LATEST ACTION
2016-01-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL

Approval history

2016-01-10Labeling · Supplement 34 · standardAP
2016-01-10Labeling · Supplement 32 · standardAP
2016-01-10Labeling · Supplement 35 · standardAP
2016-01-10Labeling · Supplement 33 · standardAP
2016-01-10Labeling · Supplement 31AP
2010-05-13Labeling · Supplement 29AP
2009-10-26Labeling · Supplement 28AP
2009-06-15Labeling · Supplement 22AP
2009-03-30Labeling · Supplement 27AP
2008-08-21Labeling · Supplement 26AP
2008-02-11Labeling · Supplement 19AP
2007-10-24Labeling · Supplement 18AP
2007-10-24Labeling · Supplement 17AP
2005-12-14Labeling · Supplement 16AP
2005-12-14Labeling · Supplement 15AP
2004-10-19Labeling · Supplement 11AP
2004-09-28Labeling · Supplement 3AP
2002-08-16Manufacturing (CMC) · Supplement 1AP
2002-01-31Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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