← FDA DRUG APPROVALS

FDA ANDA · ANDA075566

PAROXETINE HYDROCHLORIDE

Sponsor: UPSHER SMITH LABS

APPLICATION
ANDA075566
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-08
LATEST ACTION
2009-10-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL

Approval history

2009-10-26Labeling · Supplement 7AP
2009-04-21Labeling · Supplement 6AP
2005-05-17Labeling · Supplement 4AP
2004-03-08Original — 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 →