Cimetidine

ANDA 74316, held by Watson Labs Inc. Cimetidine.

As of Nov 14, 2026, ANDA 74316 (Cimetidine), held by Watson Labs Inc, was first approved by FDA on Feb 28, 1996, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 28, 1996
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 28, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cimetidine800MG · tablet;oral	Cimetidine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 7, 1998	Supplement 1Labeling	Approved	None posted
Feb 28, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74316
Drugs@FDA: Overview at FDA
Company: Watson 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