Cimetidine

ANDA 74361, held by Cycle. Cimetidine.

As of Nov 14, 2026, ANDA 74361 (Cimetidine), held by Cycle, was first approved by FDA on Dec 23, 1994, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 23, 1994
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
Dec 23, 1994	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Sep 12, 1996	Supplement 2Labeling	Approved	None posted
Dec 23, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74361
Drugs@FDA: Overview at FDA
Company: Cycle, LLC

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