Famotidine

Treats pathological hypersecretory conditions. ANDA 75718, held by Dr Reddys Labs Ltd. Famotidine.

As of Nov 15, 2026, ANDA 75718 (Famotidine), held by Dr Reddys Labs Ltd, was first approved by FDA on Apr 16, 2001, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 16, 2001
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:

active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcer recurrence. Famotidine is a histamine-2 (H 2 ) receptor antagonist indicated: In adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer (DU).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 16, 2001	Original application	Approved	Letter

Products

2 strengths and forms


Famotidine20MG · tablet;oral	Famotidine	Rx
Famotidine40MG · tablet;oral	Famotidine	Rx

All 8 submissions, including labeling and manufacturing supplements


Jul 20, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Nov 20, 2012	Supplement 15Labeling	Approved	None posted
Oct 29, 2010	Supplement 14Labeling	Approved	None posted
Jul 15, 2010	Supplement 13Labeling	Approved	None posted
Jun 29, 2007	Supplement 10Labeling	Approved	None posted
Apr 19, 2002	Supplement 3Manufacturing	Approved	None posted
Dec 13, 2001	Supplement 1Manufacturing	Approved	None posted
Apr 16, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75718
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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