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FDA ANDA · ANDA076022

FLUOXETINE HYDROCHLORIDE

Sponsor: CARLSBAD

APPLICATION
ANDA076022
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-30
LATEST ACTION
2017-01-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
FLUOXETINE HYDROCHLORIDEDiscontinued
FLUOXETINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL

Approval history

2017-01-04Labeling · Supplement 4 · standardAP
2015-02-04Labeling · Supplement 3 · standardAP
2002-01-30Original — 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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