FDA — authorised 10 December 1992
- Application: ANDA074091
- Marketing authorisation holder: OHM LABS
- Status: supplemented
FDA authorised CVP on 10 December 1992
Yes. FDA authorised it on 10 December 1992; FDA authorised it on 12 April 1993; FDA authorised it on 14 January 1998.
OHM LABS holds the US marketing authorisation.