Pepcid

NDA 19527, held by Salix Pharms. Famotidine.

As of Nov 13, 2026, NDA 19527 (Pepcid), held by Salix Pharms, was first approved by FDA on Feb 2, 1987, with 26 approved supplements and 0 published complete response letters.

First approved: Feb 2, 1987
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Jun 6, 2002	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 2, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pepcid40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for suspension;oral	Famotidine	DiscontinuedReference drug

All 27 submissions, including labeling and manufacturing supplements


Jul 23, 2024	Supplement 32Manufacturing	Approved	Label Letter
Aug 15, 2019	Supplement 31Labeling · Standard review	Approved	Letter Label
Nov 5, 2007	Supplement 28Labeling · Standard review	Approved	Letter Label
Nov 24, 2004	Supplement 27Labeling · Standard review	Approved	Label Letter
Jun 6, 2002	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Apr 25, 2001	Supplement 23Labeling · Standard review	Approved	None posted
Mar 14, 2001	Supplement 25Labeling · Standard review	Approved	None posted
Nov 27, 2000	Supplement 22Labeling · Standard review	Approved	None posted
Oct 13, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 18, 1999	Supplement 20Labeling · Standard review	Approved	Review
Oct 8, 1998	Supplement 19Labeling · Standard review	Approved	None posted
Aug 12, 1998	Supplement 16Labeling · Standard review	Approved	None posted
Oct 28, 1997	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 22, 1997	Supplement 17Labeling · Standard review	Approved	None posted
Aug 22, 1997	Supplement 8Labeling	Approved	None posted
Mar 29, 1996	Supplement 14Labeling · Standard review	Approved	None posted
Mar 29, 1996	Supplement 13Labeling · Standard review	Approved	None posted
Mar 29, 1996	Supplement 12Labeling · Standard review	Approved	None posted
Feb 1, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 29, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 10, 1991	Supplement 7Labeling	Approved	None posted
Nov 30, 1990	Supplement 9Labeling	Approved	None posted
Nov 30, 1990	Supplement 5Labeling	Approved	None posted
Nov 30, 1990	Supplement 4Labeling	Approved	None posted
Nov 23, 1988	Supplement 1Labeling	Approved	None posted
Oct 28, 1988	Supplement 3Labeling	Approved	None posted
Feb 2, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19527
Drugs@FDA: Overview at FDA
Company: Salix Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters