← FDA DRUG APPROVALS

FDA ANDA · ANDA076125

FLUVOXAMINE MALEATE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA076125
TYPE
ANDA
ORIGINAL APPROVAL
2002-04-29
LATEST ACTION
2023-08-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FLUVOXAMINE MALEATEDiscontinued
FLUVOXAMINE MALEATE 50MG · TABLET · ORAL
FLUVOXAMINE MALEATEDiscontinued
FLUVOXAMINE MALEATE 100MG · TABLET · ORAL
FLUVOXAMINE MALEATEDiscontinued
FLUVOXAMINE MALEATE 25MG · TABLET · ORAL

Approval history

2023-08-31Labeling · Supplement 15 · standardAP
2007-06-27Labeling · Supplement 14AP
2007-05-12Labeling · Supplement 13AP
2007-02-21Labeling · Supplement 12AP
2006-07-24Labeling · Supplement 11AP
2004-10-20Labeling · Supplement 4AP
2004-02-13Labeling · Supplement 3AP
2002-04-29Original — 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 →