Famotidine

As of Nov 15, 2026, ANDA 75684 (Famotidine), held by Sagent, was first approved by FDA on Apr 16, 2001, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 16, 2001
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
Apr 16, 2001	Original application	Approved	Review Letter

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jan 7, 2022	Supplement 13Labeling · Standard review	Approved	None posted
Jul 31, 2008	Supplement 5Labeling	Approved	None posted
Apr 16, 2001	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75684
Drugs@FDA: Overview at FDA
Company: Sagent 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