Cimetidine

ANDA 74506, held by Upsher Smith Labs. Cimetidine.

As of Nov 14, 2026, ANDA 74506 (Cimetidine), held by Upsher Smith Labs, was first approved by FDA on Jan 24, 1996, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 24, 1996
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 24, 1996	Original application	Approved	None posted

Products

4 strengths and forms


Cimetidine200MG · tablet;oral	Cimetidine	Discontinued
Cimetidine300MG · tablet;oral	Cimetidine	Discontinued
Cimetidine400MG · tablet;oral	Cimetidine	Discontinued
Cimetidine800MG · tablet;oral	Cimetidine	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Aug 10, 1998	Supplement 4Labeling	Approved	None posted
Apr 7, 1997	Supplement 1Manufacturing	Approved	None posted
Apr 7, 1997	Supplement 2Labeling	Approved	None posted
Apr 7, 1997	Supplement 3Manufacturing	Approved	None posted
Jan 24, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74506
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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