Cimetidine

Treats active duodenal ulcer. ANDA 74151, held by Teva. Cimetidine.

As of Nov 14, 2026, ANDA 74151 (Cimetidine), held by Teva, was first approved by FDA on May 17, 1994, with 14 approved supplements and 0 published complete response letters.

First approved: May 17, 1994
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Cimetidine tablets USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION, Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 17, 1994	Original application	Approved	None posted

Products

3 strengths and forms


Cimetidine200MG · tablet;oral	Cimetidine	Rx
Cimetidine300MG · tablet;oral	Cimetidine	Rx
Cimetidine400MG · tablet;oral	Cimetidine	Rx

All 15 submissions, including labeling and manufacturing supplements


Nov 13, 2012	Supplement 20Labeling	Approved	None posted
Mar 16, 2007	Supplement 19Labeling	Approved	None posted
Feb 1, 2000	Supplement 15Manufacturing	Approved	None posted
Jan 21, 1999	Supplement 14Manufacturing	Approved	None posted
May 18, 1998	Supplement 13Manufacturing	Approved	None posted
Mar 25, 1998	Supplement 12Manufacturing	Approved	None posted
Jun 26, 1996	Supplement 4Manufacturing	Approved	None posted
Jun 26, 1996	Supplement 5Manufacturing	Approved	None posted
Jun 26, 1996	Supplement 6Manufacturing	Approved	None posted
Jun 26, 1996	Supplement 7Manufacturing	Approved	None posted
Jan 31, 1996	Supplement 1Manufacturing	Approved	None posted
Jan 31, 1996	Supplement 2Manufacturing	Approved	None posted
Jan 31, 1996	Supplement 3Labeling	Approved	None posted
Dec 22, 1995	Supplement 9Labeling	Approved	None posted
May 17, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74151
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