Famotidine

ANDA 75400, held by Perrigo. Famotidine.

As of Nov 15, 2026, ANDA 75400 (Famotidine), held by Perrigo, was first approved by FDA on Mar 18, 2005, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 18, 2005
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 18, 2005	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Famotidine10MG · tablet;oral	Famotidine	OTC

All 5 submissions, including labeling and manufacturing supplements


Oct 22, 2019	Supplement 35Labeling · Standard review	Approved	None posted
Oct 30, 2010	Supplement 20Labeling	Approved	None posted
Nov 24, 2008	Supplement 18Manufacturing	Approved	None posted
Dec 27, 2005	Supplement 3Labeling	Approved	None posted
Mar 18, 2005	Original application	Approved	Letter

Identifiers

Application: ANDA 75400
Drugs@FDA: Overview at FDA
Company: Perrigo

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