Famotidine

Treats pathological hypersecretory conditions. ANDA 78916, held by Alembic Pharms Ltd. Famotidine.

As of Nov 15, 2026, ANDA 78916 (Famotidine), held by Alembic Pharms Ltd, was first approved by FDA on May 22, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: May 22, 2009
Supplements approved: 4
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 tablet 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 5 submissions below

Date	Submission	Status	Documents
May 22, 2009	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


May 11, 2020	Supplement 5Labeling · Standard review	Approved	None posted
May 11, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Feb 22, 2013	Supplement 2Labeling	Approved	None posted
Jul 15, 2010	Supplement 1Labeling	Approved	None posted
May 22, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78916
Drugs@FDA: Overview at FDA
Company: Alembic 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