← FDA DRUG APPROVALS

FDA ANDA · ANDA074864

RANITIDINE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA074864
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-20
LATEST ACTION
2007-08-30
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

2007-08-30Labeling · Supplement 7AP
2002-12-06Labeling · Supplement 5AP
1999-11-03Manufacturing (CMC) · Supplement 4AP
1999-11-03Manufacturing (CMC) · Supplement 2AP
1999-11-03Manufacturing (CMC) · Supplement 3AP
1998-08-03Manufacturing (CMC) · Supplement 1AP
1997-10-20OriginalAP
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 →