Cimetidine

As of Nov 14, 2026, ANDA 74948 (Cimetidine), held by Apotex, was first approved by FDA on Jun 19, 1998, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 19, 1998
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 19, 1998	Original application	Approved	Letter

Products

2 strengths and forms


Cimetidine100MG · tablet;oral	Cimetidine	Discontinued
Cimetidine200MG · tablet;oral	Cimetidine	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jul 26, 2002	Supplement 1Manufacturing	Approved	None posted
Jul 26, 2002	Supplement 2Manufacturing	Approved	None posted
Jul 26, 2002	Supplement 3Manufacturing	Approved	None posted
Jul 26, 2002	Supplement 4Manufacturing	Approved	None posted
Jul 26, 2002	Supplement 5Labeling	Approved	None posted
Jun 19, 1998	Original application	Approved	Letter

Identifiers

Application: ANDA 74948
Drugs@FDA: Overview at FDA
Company: Apotex

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