Famotidine

As of Nov 15, 2026, ANDA 75611 (Famotidine), held by Apotex, was first approved by FDA on Jul 23, 2001, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 23, 2001
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jul 23, 2001	Original application	Approved	Letter Label Review

Products

2 strengths and forms


Famotidine20MG · tablet;oral	Famotidine	Discontinued
Famotidine40MG · tablet;oral	Famotidine	Discontinued

All 5 submissions, including labeling and manufacturing supplements


May 12, 2020	Supplement 11Labeling · Standard review	Approved	None posted
May 12, 2020	Supplement 10Labeling · Standard review	Approved	None posted
May 16, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Dec 21, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Jul 23, 2001	Original application	Approved	Letter Label Review

Identifiers

Application: ANDA 75611
Drugs@FDA: Overview at FDA
Company: Apotex

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