FDA — authorised 4 September 1980
- Application: NDA018164
- Marketing authorisation holder: ATNAHS PHARMA US
- Local brand name: ANAPROX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Aleve in United States
FDA authorised Aleve on 4 September 1980
Marketing authorisations
FDA
- Status: approved
Other Immunology approved in United States
Frequently asked questions
Is Aleve approved in United States?
Yes. FDA authorised it on 4 September 1980; FDA has authorised it.
Who is the marketing authorisation holder for Aleve in United States?
ATNAHS PHARMA US holds the US marketing authorisation.