← FDA DRUG APPROVALS

FDA ANDA · ANDA075165

RANITIDINE HYDROCHLORIDE

Sponsor: HERITAGE PHARMA AVET

APPLICATION
ANDA075165
TYPE
ANDA
ORIGINAL APPROVAL
1998-09-30
LATEST ACTION
2010-09-02
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

2010-09-02Manufacturing (CMC) · Supplement 7AP
2009-05-27Labeling · Supplement 5AP
1999-11-23Manufacturing (CMC) · Supplement 1AP
1998-09-30Original — 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 →