← FDA DRUG APPROVALS

FDA ANDA · ANDA075755

FLUOXETINE HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA075755
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-02
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 27 · standardAP
2021-09-20Labeling · Supplement 26 · standardAP
2017-01-04Labeling · Supplement 23 · standardAP
2016-09-14Labeling · Supplement 22 · standardAP
2014-11-17Labeling · Supplement 21 · standard — Label ↗AP
2014-11-14Labeling · Supplement 19 · standardAP
2009-04-06Labeling · Supplement 16AP
2009-02-13Labeling · Supplement 17AP
2008-10-08Labeling · Supplement 15AP
2008-04-17Labeling · Supplement 14AP
2007-08-03Labeling · Supplement 13AP
2007-08-03Labeling · Supplement 12AP
2005-05-11Labeling · Supplement 8AP
2005-05-11Labeling · Supplement 10AP
2002-05-03Manufacturing (CMC) · Supplement 1AP
2001-08-02Original — Review ↗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 →