Cimetidine

ANDA 74339, held by Novitium Pharma. Cimetidine.

As of Nov 14, 2026, ANDA 74339 (Cimetidine), held by Novitium Pharma, was first approved by FDA on Jun 23, 1995, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1995
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
Jun 23, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cimetidine800MG · tablet;oral	Cimetidine	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 18, 2002	Supplement 5Manufacturing	Approved	None posted
Aug 27, 2001	Supplement 4Manufacturing	Approved	None posted
May 14, 1996	Supplement 1Manufacturing	Approved	None posted
Jun 23, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74339
Drugs@FDA: Overview at FDA
Company: Novitium Pharma

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