Cimetidine

ANDA 74568, held by Pliva. Cimetidine.

As of Nov 14, 2026, ANDA 74568 (Cimetidine), held by Pliva, was first approved by FDA on Feb 27, 1997, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 27, 1997
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
Feb 27, 1997	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 5 submissions, including labeling and manufacturing supplements


Mar 3, 2005	Supplement 9Labeling	Approved	None posted
Jul 7, 2000	Supplement 3Manufacturing	Approved	None posted
May 10, 2000	Supplement 2Manufacturing	Approved	None posted
Feb 17, 1998	Supplement 1Manufacturing	Approved	None posted
Feb 27, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74568
Drugs@FDA: Overview at FDA
Company: PLIVA

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