Famotidine

As of Nov 15, 2026, ANDA 75610 (Famotidine), held by Apotex, was first approved by FDA on Mar 12, 2002, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 12, 2002
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 12, 2002	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Famotidine10MG · tablet;oral	Famotidine	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Nov 8, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Nov 8, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Nov 4, 2014	Supplement 6Manufacturing	Approved	None posted
Mar 12, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 75610
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