Acephen

ANDA 72237, held by Cosette Pharms Nc. Acetaminophen.

As of Nov 13, 2026, ANDA 72237 (Acephen), held by Cosette Pharms Nc, was first approved by FDA on Mar 27, 1992, with 8 approved supplements and 0 published complete response letters.

First approved: Mar 27, 1992
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Mar 27, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acephen650MG · suppository;rectal	Acetaminophen	Discontinued

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 10, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Nov 10, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Sep 24, 2013	Supplement 9Labeling	Approved	None posted
Aug 19, 2010	Supplement 8Labeling	Approved	None posted
Aug 19, 2010	Supplement 7Labeling	Approved	None posted
Apr 29, 1999	Supplement 3Manufacturing	Approved	None posted
Oct 4, 1996	Supplement 2Manufacturing	Approved	None posted
Jul 10, 1992	Supplement 1Labeling	Approved	None posted
Mar 27, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 72237
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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