APPLICATION
NDA019527
TYPE
NDA
ORIGINAL APPROVAL
1987-02-02
LATEST ACTION
2024-07-23
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
PEPCID · ReferenceDiscontinued
FAMOTIDINE 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
Approval history
2001-04-25Labeling · Supplement 23 · standardAP
2001-03-14Labeling · Supplement 25 · standardAP
2000-11-27Labeling · Supplement 22 · standardAP
1999-10-13Manufacturing (CMC) · Supplement 21 · standardAP
1998-10-08Labeling · Supplement 19 · standardAP
1998-08-12Labeling · Supplement 16 · standardAP
1997-10-28Manufacturing (CMC) · Supplement 18 · standardAP
1997-08-22Labeling · Supplement 8AP
1997-08-22Labeling · Supplement 17 · standardAP
1996-03-29Labeling · Supplement 14 · standardAP
1996-03-29Labeling · Supplement 12 · standardAP
1996-03-29Labeling · Supplement 13 · standardAP
1996-02-01Manufacturing (CMC) · Supplement 15 · standardAP
1995-09-29Manufacturing (CMC) · Supplement 2 · standardAP
1991-12-10Labeling · Supplement 7AP
1990-11-30Labeling · Supplement 5AP
1990-11-30Labeling · Supplement 4AP
1990-11-30Labeling · Supplement 9AP
1988-11-23Labeling · Supplement 1AP
1988-10-28Labeling · Supplement 3AP
1987-02-02Type 3 - New Dosage Form · Original · standardAP
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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