Acetaminophen

ANDA 70608, held by Perrigo New York. Acetaminophen.

As of Nov 13, 2026, ANDA 70608 (Acetaminophen), held by Perrigo New York, was first approved by FDA on Dec 1, 1986, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 1, 1986
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses temporarily

reduces fever
relieves minor aches, pains, and headache

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 1, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetaminophen650MG · suppository;rectal	Acetaminophen	OTC

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 24, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Jun 10, 2011	Supplement 9Labeling	Approved	None posted
Aug 6, 2010	Supplement 8Labeling	Approved	None posted
Aug 31, 1992	Supplement 5Labeling	Approved	None posted
Oct 23, 1987	Supplement 2Manufacturing	Approved	None posted
Dec 1, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70608
Drugs@FDA: Overview at FDA
Company: Perrigo New York

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