FDA — authorised 30 January 1992
- Application: ANDA071935
- Marketing authorisation holder: AMNEAL PHARMS NY
- Indication: Labeling
- Status: approved
🇺🇸 Advil in United States
FDA authorised Advil on 30 January 1992
Marketing authorisations
FDA — authorised 9 March 2015
- Application: NDA022348
- Marketing authorisation holder: CUMBERLAND PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 May 2019
- Application: ANDA210149
- Marketing authorisation holder: GUARDIAN DRUG
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 1 March 2023
- Application: NDA209471
- Marketing authorisation holder: AFT PHARMS US
- Indication: Type 4 - New Combination
- Status: approved
FDA — authorised 14 September 2023
- Application: ANDA215777
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
Advil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Advil approved in United States?
Yes. FDA authorised it on 30 January 1992; FDA authorised it on 9 March 2015; FDA authorised it on 15 May 2019.
Who is the marketing authorisation holder for Advil in United States?
AMNEAL PHARMS NY holds the US marketing authorisation.