Famotidine

ANDA 75942, held by Apotex Inc. Famotidine.

As of Nov 15, 2026, ANDA 75942 (Famotidine), held by Apotex Inc, was first approved by FDA on Aug 2, 2002, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 2, 2002
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 2, 2002	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Famotidine10MG/ML · injectable;injection	Famotidine	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Sep 25, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Nov 20, 2002	Supplement 1Manufacturing	Approved	None posted
Aug 2, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75942
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