← FDA DRUG APPROVALS

FDA NDA · NDA020095

ZANTAC 300

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020095
TYPE
NDA
ORIGINAL APPROVAL
1994-03-08
LATEST ACTION
2002-01-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ZANTAC 300 · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ZANTAC 150 · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2002-01-15Manufacturing (CMC) · Supplement 14 · standardAP
2002-01-07Labeling · Supplement 13 · standard — Letter ↗AP
2001-05-09Labeling · Supplement 12 · standardAP
1999-10-29Labeling · Supplement 7 · standard — Review ↗AP
1999-10-29Labeling · Supplement 11 · standardAP
1999-10-22Labeling · Supplement 9 · standardAP
1999-10-22Labeling · Supplement 10 · standardAP
1997-09-12Manufacturing (CMC) · Supplement 8 · standardAP
1996-11-27Labeling · Supplement 6 · standard — Review ↗AP
1995-03-29Labeling · Supplement 5 · standardAP
1994-11-14Labeling · Supplement 4 · standardAP
1994-11-03Labeling · Supplement 2 · standardAP
1994-04-04Labeling · Supplement 1 · standardAP
1994-03-08Type 3 - New Dosage Form · Original · standardAP
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 →