← FDA DRUG APPROVALS

FDA NDA · NDA020249

PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA020249
TYPE
NDA
ORIGINAL APPROVAL
1994-02-18
LATEST ACTION
2007-11-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER · ReferenceDiscontinued
FAMOTIDINE 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2007-11-05Labeling · Supplement 13 · standard — Letter ↗AP
2002-06-06Efficacy · Supplement 11 · standard — Review ↗AP
2001-04-25Labeling · Supplement 10 · standardAP
2001-03-14Labeling · Supplement 12 · standard — Letter ↗AP
1999-03-18Labeling · Supplement 9 · standard — Review ↗AP
1998-08-19Manufacturing (CMC) · Supplement 6 · standardAP
1998-08-12Labeling · Supplement 7 · standardAP
1997-11-12Labeling · Supplement 8 · standardAP
1997-03-03Manufacturing (CMC) · Supplement 4 · standardAP
1996-06-26Manufacturing (CMC) · Supplement 3 · standardAP
1996-05-31Labeling · Supplement 5 · standardAP
1995-06-29Labeling · Supplement 2 · standardAP
1995-06-29Labeling · Supplement 1 · standardAP
1994-02-18Type 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 →