FDA — authorised 28 February 2023
- Application: ANDA214836
- Marketing authorisation holder: L PERRIGO CO
- Local brand name: ACETAMINOPHEN AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Acetaminophen and Ibuprofen in United States
FDA authorised Acetaminophen and Ibuprofen on 28 February 2023
Marketing authorisations
FDA — authorised 10 July 2023
- Application: ANDA216994
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: ACETAMINOPHEN AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2023
- Application: ANDA216592
- Marketing authorisation holder: GRANULES
- Local brand name: ACETAMINOPHEN AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 2023
- Application: ANDA216999
- Marketing authorisation holder: BIONPHARMA
- Local brand name: ACETAMINOPHEN AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2024
- Application: ANDA218359
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ACETAMINOPHEN AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2024
- Application: ANDA218311
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ACETAMINOPHEN AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 2024
- Application: ANDA218247
- Marketing authorisation holder: DR REDDYS
- Local brand name: ACETAMINOPHEN AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 2025
- Application: ANDA220126
- Marketing authorisation holder: LNK INTL INC
- Local brand name: ACETAMINOPHEN AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 January 2026
- Application: ANDA219053
- Marketing authorisation holder: TARO
- Local brand name: ACETAMINOPHEN AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is Acetaminophen and Ibuprofen approved in United States?
Yes. FDA authorised it on 28 February 2023; FDA authorised it on 10 July 2023; FDA authorised it on 13 July 2023.
Who is the marketing authorisation holder for Acetaminophen and Ibuprofen in United States?
L PERRIGO CO holds the US marketing authorisation.