Acetaminophen

ANDA 75077, held by Perrigo. Acetaminophen.

As of Nov 13, 2026, ANDA 75077 (Acetaminophen), held by Perrigo, was first approved by FDA on Feb 25, 2000, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 25, 2000
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses

temporarily relieves minor aches and pains due to:
minor pain of arthritis
muscular aches
backache
premenstrual and menstrual cramps
the common cold
headache
toothache
temporarily reduces fever

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 25, 2000	Original application	Approved	Review Letter

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 16, 2019	Supplement 55Labeling · Standard review	Approved	None posted
Jan 10, 2016	Supplement 40Labeling · Standard review	Approved	None posted
Nov 30, 2013	Supplement 32Labeling	Approved	None posted
Oct 25, 2010	Supplement 28Labeling	Approved	None posted
Feb 10, 2005	Supplement 6Labeling	Approved	None posted
Dec 29, 2000	Supplement 1Labeling	Approved	None posted
Feb 25, 2000	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75077
Drugs@FDA: Overview at FDA
Company: Perrigo

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