Cimetidine

ANDA 74961, held by Contract Pharmacal. Cimetidine.

As of Nov 14, 2026, ANDA 74961 (Cimetidine), held by Contract Pharmacal, 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

1 strengths and forms

Product	Active ingredient	Marketing
Cimetidine200MG · tablet;oral	Cimetidine	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Sep 21, 2000	Supplement 6Manufacturing	Approved	None posted
Aug 30, 2000	Supplement 5Manufacturing	Approved	None posted
Jan 13, 2000	Supplement 3Labeling	Approved	None posted
Jan 26, 1999	Supplement 2Labeling	Approved	None posted
Nov 23, 1998	Supplement 1Manufacturing	Approved	None posted
Jun 19, 1998	Original application	Approved	Letter

Identifiers

Application: ANDA 74961
Drugs@FDA: Overview at FDA
Company: Contract Pharmacal Corporation

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