← FDA DRUG APPROVALS

FDA ANDA · ANDA075807

FLUOXETINE HYDROCHLORIDE

Sponsor: REGCON HOLDINGS

APPLICATION
ANDA075807
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-29
LATEST ACTION
2006-01-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2006-01-31Labeling · Supplement 7AP
2005-06-07Labeling · Supplement 5AP
2005-06-07Labeling · Supplement 4AP
2004-09-13Labeling · Supplement 1AP
2002-01-29Original — 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →