Cimetidine

ANDA 75345, held by Ivax Sub Teva Pharms. Cimetidine.

As of Nov 14, 2026, ANDA 75345 (Cimetidine), held by Ivax Sub Teva Pharms, was first approved by FDA on Jun 16, 1999, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 16, 1999
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 16, 1999	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cimetidine200MG · tablet;oral	Cimetidine	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Sep 26, 2006	Supplement 14Labeling	Approved	None posted
Nov 1, 2004	Supplement 12Labeling	Approved	None posted
Jul 29, 2002	Supplement 3Manufacturing	Approved	None posted
Jul 15, 2002	Supplement 2Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 1Manufacturing	Approved	None posted
Jun 16, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75345
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