Pepcid Preservative Free In Plastic Container

NDA 20249, held by Merck Sharp Dohme. Famotidine.

As of Nov 14, 2026, NDA 20249 (Pepcid Preservative Free In Plastic Container), held by Merck Sharp Dohme, was first approved by FDA on Feb 18, 1994, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 18, 1994
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Jun 6, 2002	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Feb 18, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pepcid Preservative Free In Plastic Container0.4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Famotidine	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Nov 5, 2007	Supplement 13Labeling · Standard review	Approved	Letter Label
Jun 6, 2002	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 25, 2001	Supplement 10Labeling · Standard review	Approved	None posted
Mar 14, 2001	Supplement 12Labeling · Standard review	Approved	Letter Label
Mar 18, 1999	Supplement 9Labeling · Standard review	Approved	Review
Aug 19, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 12, 1998	Supplement 7Labeling · Standard review	Approved	None posted
Nov 12, 1997	Supplement 8Labeling · Standard review	Approved	None posted
Mar 3, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 26, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
May 31, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Jun 29, 1995	Supplement 1Labeling · Standard review	Approved	None posted
Jun 29, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Feb 18, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20249
Drugs@FDA: Overview at FDA
Company: Merck Sharp & Dohme

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