Famotidine

ANDA 75639, held by Sun Pharm Industries. Famotidine.

As of Nov 15, 2026, ANDA 75639 (Famotidine), held by Sun Pharm Industries, was first approved by FDA on Dec 12, 2001, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 12, 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
Dec 12, 2001	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Mar 4, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 9Labeling · Standard review	Approved	None posted
May 5, 2003	Supplement 2Labeling	Approved	None posted
Dec 12, 2001	Original application	Approved	None posted

Identifiers

Application: ANDA 75639
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