Acephen

ANDA 72344, held by Cosette Pharms Nc. Acetaminophen.

As of Nov 14, 2026, ANDA 72344 (Acephen), held by Cosette Pharms Nc, was first approved by FDA on Mar 27, 1992, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 27, 1992
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acephen325MG · suppository;rectal	Acetaminophen	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Apr 2, 2015	Supplement 9Labeling	Approved	None posted
Aug 19, 2010	Supplement 8Labeling	Approved	None posted
Apr 29, 1999	Supplement 4Manufacturing	Approved	None posted
Oct 4, 1996	Supplement 3Manufacturing	Approved	None posted
Nov 1, 1995	Supplement 2Manufacturing	Approved	None posted
Apr 6, 1993	Supplement 1Labeling	Approved	None posted
Mar 27, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 72344
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