FDA — authorised 13 July 1973
- Application: ANDA080951
- Marketing authorisation holder: IMPAX LABS
- Local brand name: VITAMIN D
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Infuvite Adult on 13 July 1973
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 13 July 1973; FDA authorised it on 16 October 1978; FDA authorised it on 18 May 2000.
IMPAX LABS holds the US marketing authorisation.