← FDA DRUG APPROVALS

FDA ANDA · ANDA078542

RANITIDINE HYDROCHLORIDE

Sponsor: GLENMARK PHARMS

APPLICATION
ANDA078542
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-19
LATEST ACTION
2011-07-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 300MG BASE · TABLET · ORAL

Approval history

2011-07-31Labeling · Supplement 2AP
2010-04-30Labeling · Supplement 1AP
2008-11-19OriginalAP
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 →