Pepcid, Pepcid Preservative Free

NDA 19510, held by Merck. Famotidine.

As of Nov 13, 2026, NDA 19510 (Pepcid, Pepcid Preservative Free), held by Merck, was first approved by FDA on Nov 4, 1986, with 29 approved supplements and 0 published complete response letters.

First approved: Nov 4, 1986
Review: Standard
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Jun 6, 2002	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 4, 1986	Original applicationNew dosage form · Standard review	Approved	Label

Products

2 strengths and forms


Pepcid10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Famotidine	DiscontinuedReference drug
Pepcid Preservative Free10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Famotidine	DiscontinuedReference drug

All 30 submissions, including labeling and manufacturing supplements


Nov 5, 2007	Supplement 31Labeling · Standard review	Approved	Letter Label
Aug 1, 2002	Supplement 30Manufacturing · Standard review	Approved	None posted
Jun 6, 2002	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 25, 2001	Supplement 27Labeling · Standard review	Approved	None posted
Mar 14, 2001	Supplement 29Labeling · Standard review	Approved	Letter Label
May 6, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 18, 1999	Supplement 26Labeling · Standard review	Approved	Review
Jan 28, 1999	Supplement 25Labeling · Standard review	Approved	None posted
Aug 12, 1998	Supplement 20Labeling · Standard review	Approved	None posted
Dec 19, 1997	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 12, 1997	Supplement 23Labeling · Standard review	Approved	None posted
May 16, 1997	Supplement 22Labeling · Standard review	Approved	None posted
May 16, 1997	Supplement 11Labeling	Approved	None posted
May 8, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 30, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 29, 1995	Supplement 18Labeling · Standard review	Approved	None posted
Jun 29, 1995	Supplement 17Labeling · Standard review	Approved	None posted
Jun 29, 1995	Supplement 16Labeling · Standard review	Approved	None posted
Jun 29, 1995	Supplement 9Labeling	Approved	None posted
Jan 7, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 10, 1991	Supplement 10Labeling	Approved	None posted
Nov 30, 1990	Supplement 12Labeling	Approved	None posted
Nov 30, 1990	Supplement 8Labeling	Approved	None posted
Nov 30, 1990	Supplement 7Labeling	Approved	None posted
Nov 23, 1988	Supplement 4Labeling	Approved	None posted
Oct 28, 1988	Supplement 6Labeling	Approved	None posted
Jun 3, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 1, 1987	Supplement 2Labeling	Approved	None posted
Dec 12, 1986	Supplement 1Labeling	Approved	None posted
Nov 4, 1986	Original applicationNew dosage form · Standard review	Approved	Label

Identifiers

Application: NDA 19510
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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