← FDA DRUG APPROVALS

FDA ANDA · ANDA211696

FLUOXETINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC

APPLICATION
ANDA211696
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-30
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-08-18Labeling · Supplement 4 · standardAP
2021-09-21Labeling · Supplement 2 · standardAP
2019-01-30UNKNOWN · Original · standardAP
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 →