FDA — authorised 13 December 1993
- Application: ANDA073594
- Marketing authorisation holder: DR REDDYS LABS SA
- Status: supplemented
FDA authorised Levora on 13 December 1993
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 December 1993; FDA has authorised it.
DR REDDYS LABS SA holds the US marketing authorisation.