Cimetidine

ANDA 74349, held by Watson Labs Inc. Cimetidine.

As of Nov 14, 2026, ANDA 74349 (Cimetidine), held by Watson Labs Inc, was first approved by FDA on Aug 30, 1996, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 30, 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
Aug 30, 1996	Original application	Approved	None posted

Products

3 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Mar 3, 1998	Supplement 1Manufacturing	Approved	None posted
Aug 30, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74349
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