Acetaminophen

ANDA 76200, held by Ohm Labs. Acetaminophen.

As of Nov 13, 2026, ANDA 76200 (Acetaminophen), held by Ohm Labs, was first approved by FDA on Mar 19, 2002, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 19, 2002
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Mar 19, 2002	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetaminophen650MG · tablet, extended release;oral	Acetaminophen	OTC

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 23, 2015	Supplement 22Labeling · Standard review	Approved	None posted
Sep 25, 2014	Supplement 21Labeling · Standard review	Approved	None posted
Sep 25, 2014	Supplement 20Labeling · Standard review	Approved	None posted
Sep 25, 2014	Supplement 19Labeling	Approved	None posted
Jul 28, 2010	Supplement 16Labeling	Approved	None posted
Jan 22, 2010	Supplement 15Labeling	Approved	None posted
Nov 23, 2009	Supplement 14Labeling	Approved	None posted
Feb 17, 2009	Supplement 12Labeling	Approved	None posted
Aug 11, 2004	Supplement 5	Approved	Review
Dec 3, 2002	Supplement 4Manufacturing	Approved	Review
Dec 3, 2002	Supplement 3Manufacturing	Approved	Review
Dec 3, 2002	Supplement 2Manufacturing	Approved	Review
Oct 15, 2002	Supplement 1Manufacturing	Approved	Review
Mar 19, 2002	Original application	Approved	Review Letter

Identifiers

Application: ANDA 76200
Drugs@FDA: Overview at FDA
Company: Ohm 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