Famotidine

Treats pathological hypersecretory conditions. ANDA 75511, held by Ivax Sub Teva Pharms. Famotidine.

As of Nov 15, 2026, ANDA 75511 (Famotidine), held by Ivax Sub Teva Pharms, was first approved by FDA on Apr 16, 2001, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 16, 2001
Supplements approved: 8
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 tablets are 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). active gastric ulcer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 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 9 submissions, including labeling and manufacturing supplements


Oct 22, 2019	Supplement 23Labeling · Standard review	Approved	None posted
Dec 13, 2014	Supplement 18Labeling · Standard review	Approved	None posted
Dec 19, 2012	Supplement 15Labeling	Approved	None posted
Jul 6, 2010	Supplement 13Labeling	Approved	None posted
Feb 27, 2008	Supplement 8Labeling	Approved	None posted
Nov 19, 2003	Supplement 5Labeling	Approved	None posted
Dec 20, 2002	Supplement 2Manufacturing	Approved	None posted
May 8, 2002	Supplement 1Manufacturing	Approved	None posted
Apr 16, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75511
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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