Cimetidine

ANDA 74365, held by Teva. Cimetidine.

As of Nov 14, 2026, ANDA 74365 (Cimetidine), held by Teva, was first approved by FDA on Feb 28, 1995, with 21 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1995
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Feb 28, 1995	Original application	Approved	None posted

Products

4 strengths and forms


Cimetidine200MG · tablet;oral	Cimetidine	Discontinued
Cimetidine300MG · tablet;oral	Cimetidine	Discontinued
Cimetidine400MG · tablet;oral	Cimetidine	Discontinued
Cimetidine800MG · tablet;oral	Cimetidine	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 21Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 20Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 19Manufacturing	Approved	None posted
Dec 7, 2000	Supplement 18Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 17Manufacturing	Approved	None posted
Sep 10, 1999	Supplement 16Manufacturing	Approved	None posted
Sep 10, 1999	Supplement 15Manufacturing	Approved	None posted
Sep 10, 1999	Supplement 14Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 13Manufacturing	Approved	None posted
Apr 22, 1997	Supplement 11Labeling	Approved	None posted
Mar 11, 1997	Supplement 12Manufacturing	Approved	None posted
Jan 7, 1997	Supplement 9Manufacturing	Approved	None posted
Nov 26, 1996	Supplement 10Manufacturing	Approved	None posted
Jul 12, 1996	Supplement 8Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 7Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 6Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 5Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 4Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 3Manufacturing	Approved	None posted
May 25, 1995	Supplement 2Manufacturing	Approved	None posted
May 25, 1995	Supplement 1Manufacturing	Approved	None posted
Feb 28, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74365
Drugs@FDA: Overview at FDA
Company: Teva 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