FDA — authorised 15 April 2014
- Application: NDA020802
- Marketing authorisation holder: HALEON US HOLDINGS
- Indication: Labeling
- Status: approved
🇺🇸 Excedrin Extra Strength Pain Reliever in United States
FDA authorised Excedrin Extra Strength Pain Reliever on 15 April 2014
Marketing authorisations
FDA — authorised 13 July 2023
- Application: ANDA216592
- Marketing authorisation holder: GRANULES
- Status: approved
FDA — authorised 23 August 2024
- Application: ANDA218247
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA
- Marketing authorisation holder: HALEON US HOLDINGS
- Status: approved
Excedrin Extra Strength Pain Reliever 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 Excedrin Extra Strength Pain Reliever approved in United States?
Yes. FDA authorised it on 15 April 2014; FDA authorised it on 13 July 2023; FDA authorised it on 23 August 2024.
Who is the marketing authorisation holder for Excedrin Extra Strength Pain Reliever in United States?
HALEON US HOLDINGS holds the US marketing authorisation.