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FDA NDA · NDA019510

PEPCID PRESERVATIVE FREE

Sponsor: MERCK

APPLICATION
NDA019510
TYPE
NDA
ORIGINAL APPROVAL
1986-11-04
LATEST ACTION
2007-11-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

PEPCID PRESERVATIVE FREE · ReferenceDiscontinued
FAMOTIDINE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PEPCID · ReferenceDiscontinued
FAMOTIDINE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2007-11-05Labeling · Supplement 31 · standard — Letter ↗AP
2002-08-01Manufacturing (CMC) · Supplement 30 · standardAP
2002-06-06Efficacy · Supplement 28 · standard — Label ↗AP
2001-04-25Labeling · Supplement 27 · standardAP
2001-03-14Labeling · Supplement 29 · standard — Letter ↗AP
1999-05-06Manufacturing (CMC) · Supplement 21 · standardAP
1999-03-18Labeling · Supplement 26 · standard — Review ↗AP
1999-01-28Labeling · Supplement 25 · standardAP
1998-08-12Labeling · Supplement 20 · standardAP
1997-12-19Manufacturing (CMC) · Supplement 24 · standardAP
1997-11-12Labeling · Supplement 23 · standardAP
1997-05-16Labeling · Supplement 11AP
1997-05-16Labeling · Supplement 22 · standardAP
1996-05-08Manufacturing (CMC) · Supplement 15 · standardAP
1996-01-30Manufacturing (CMC) · Supplement 19 · standardAP
1995-06-29Labeling · Supplement 9AP
1995-06-29Labeling · Supplement 17 · standardAP
1995-06-29Labeling · Supplement 18 · standardAP
1995-06-29Labeling · Supplement 16 · standardAP
1992-01-07Manufacturing (CMC) · Supplement 5 · standardAP
1991-12-10Labeling · Supplement 10AP
1990-11-30Labeling · Supplement 7AP
1990-11-30Labeling · Supplement 8AP
1990-11-30Labeling · Supplement 12AP
1988-11-23Labeling · Supplement 4AP
1988-10-28Labeling · Supplement 6AP
1987-06-03Manufacturing (CMC) · Supplement 3 · standardAP
1987-04-01Labeling · Supplement 2AP
1986-12-12Labeling · Supplement 1AP
1986-11-04Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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