← FDA DRUG APPROVALS

FDA ANDA · ANDA075865

FLUOXETINE HYDROCHLORIDE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA075865
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-28
LATEST ACTION
2014-11-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL

Approval history

2014-11-17Labeling · Supplement 12 · standardAP
2005-11-17Labeling · Supplement 11AP
2004-08-30Labeling · Supplement 4AP
2002-02-28Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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