Famotidine

ANDA 206531, held by Aurobindo Pharma. Famotidine.

As of Nov 15, 2026, ANDA 206531 (Famotidine), held by Aurobindo Pharma, was first approved by FDA on Apr 26, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 26, 2016
Review: Standard
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
Apr 26, 2016	Original application	Approved	None posted

Products

2 strengths and forms


Famotidine10MG · tablet;oral	Famotidine	OTC
Famotidine20MG · tablet;oral	Famotidine	OTC

All 5 submissions, including labeling and manufacturing supplements


Aug 25, 2022	Supplement 18Labeling · Standard review	Approved	None posted
Jul 15, 2022	Supplement 17Manufacturing	Approved	None posted
Sep 11, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Sep 11, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Apr 26, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206531
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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