FDA — authorised 5 April 2002
- Application: ANDA075863
- Marketing authorisation holder: BARR
- Local brand name: KARIVA
- Indication: TABLET — ORAL-28
- Status: approved
FDA authorised Kariva® on 5 April 2002
Yes. FDA authorised it on 5 April 2002.
BARR holds the US marketing authorisation.