Cimetidine

ANDA 74401, held by Ivax Sub Teva Pharms. Cimetidine.

As of Nov 14, 2026, ANDA 74401 (Cimetidine), held by Ivax Sub Teva Pharms, was first approved by FDA on May 30, 1995, with 6 approved supplements and 0 published complete response letters.

First approved: May 30, 1995
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
May 30, 1995	Original application	Approved	None posted

Products

3 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Aug 18, 1999	Supplement 6Manufacturing	Approved	None posted
May 30, 1997	Supplement 5Manufacturing	Approved	None posted
Oct 30, 1996	Supplement 1Manufacturing	Approved	None posted
Oct 30, 1996	Supplement 2Manufacturing	Approved	None posted
Oct 30, 1996	Supplement 3Manufacturing	Approved	None posted
Oct 30, 1996	Supplement 4Labeling	Approved	None posted
May 30, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74401
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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