← FDA DRUG APPROVALS

FDA ANDA · ANDA204134

PAROXETINE

Sponsor: LUPIN

APPLICATION
ANDA204134
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-20
LATEST ACTION
2017-01-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 25MG BASE · TABLET, EXTENDED RELEASE · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
PAROXETINE HYDROCHLORIDEDiscontinued
PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2017-01-20UNKNOWN · OriginalAP
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 →