Acetaminophen And Ibuprofen

ANDA 216592, held by Granules. Acetaminophen; Ibuprofen.

As of Nov 15, 2026, ANDA 216592 (Acetaminophen And Ibuprofen), held by Granules, was first approved by FDA on Jul 13, 2023, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 13, 2023
Review: Standard
Supplements approved: 3
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: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 13, 2023	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetaminophen And Ibuprofen250MG;125MG · tablet;oral	Acetaminophen; Ibuprofen	OTC

All 4 submissions, including labeling and manufacturing supplements


Dec 17, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Oct 1, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Mar 27, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Jul 13, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 216592
Drugs@FDA: Overview at FDA
Company: Granules India

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