← FDA DRUG APPROVALS

FDA ANDA · ANDA075208

RANITIDINE HYDROCHLORIDE

Sponsor: WOCKHARDT LTD

APPLICATION
ANDA075208
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-17
LATEST ACTION
2005-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2005-01-18Labeling · Supplement 7AP
2002-04-09Manufacturing (CMC) · Supplement 4AP
2002-04-09Manufacturing (CMC) · Supplement 2AP
2002-04-09Manufacturing (CMC) · Supplement 3AP
1998-12-17Original — Letter ↗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 →