Acetaminophen

ANDA 207229, held by Aurobindo Pharma. Acetaminophen.

As of Nov 13, 2026, ANDA 207229 (Acetaminophen), held by Aurobindo Pharma, was first approved by FDA on Nov 9, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 9, 2016
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Nov 9, 2016	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 13, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Apr 13, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Apr 13, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Apr 13, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Nov 9, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 207229
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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