FDA — authorised 21 December 2005
- Application: NDA021393
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL PM
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Ibuprofen and Diphenhydramine Citrate in United States
FDA authorised Ibuprofen and Diphenhydramine Citrate on 21 December 2005
Marketing authorisations
FDA — authorised 21 December 2005
- Application: NDA021394
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL PM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 July 2009
- Application: ANDA090619
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: IBUPROFEN AND DIPHENHYDRAMINE CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2022
- Application: ANDA216204
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: IBUPROFEN AND DIPHENHYDRAMINE CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 2024
- Application: ANDA211404
- Marketing authorisation holder: PLD ACQUISITIONS LLC
- Local brand name: IBUPROFEN AND DIPHENHYDRAMINE CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Ibuprofen and Diphenhydramine Citrate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Ibuprofen and Diphenhydramine Citrate approved in United States?
Yes. FDA authorised it on 21 December 2005; FDA authorised it on 21 December 2005; FDA authorised it on 8 July 2009.
Who is the marketing authorisation holder for Ibuprofen and Diphenhydramine Citrate in United States?
HALEON US HOLDINGS holds the US marketing authorisation.