FDA — authorised 14 October 1994
- Application: NDA020067
- Marketing authorisation holder: ATNAHS PHARMA US
- Local brand name: EC-NAPROSYN
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA authorised EC naproxen on 14 October 1994
Yes. FDA authorised it on 14 October 1994.
ATNAHS PHARMA US holds the US marketing authorisation.