Famotidine

ANDA 77351, held by Perrigo R And D. Famotidine.

As of Nov 15, 2026, ANDA 77351 (Famotidine), held by Perrigo R And D, was first approved by FDA on Sep 25, 2006, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2006
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Sep 25, 2006	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Famotidine20MG · tablet;oral	Famotidine	OTC

All 4 submissions, including labeling and manufacturing supplements


Aug 18, 2021	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 18, 2021	Supplement 23Labeling · Standard review	Approved	None posted
Apr 26, 2016	Supplement 18Manufacturing	Approved	None posted
Sep 25, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77351
Drugs@FDA: Overview at FDA
Company: Perrigo R&D

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