Famotidine

ANDA 90283, held by Sun Pharm Inds Ltd. Famotidine.

As of Nov 15, 2026, ANDA 90283 (Famotidine), held by Sun Pharm Inds Ltd, was first approved by FDA on Nov 17, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 17, 2009
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
Nov 17, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Famotidine10MG · tablet;oral	Famotidine	Discontinued
Famotidine20MG · tablet;oral	Famotidine	Discontinued

All 3 submissions, including labeling and manufacturing supplements


May 11, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Sep 2, 2015	Supplement 2Labeling	Approved	None posted
Nov 17, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90283
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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