FDA — authorised 15 August 1957
- Application: NDA010585
- Marketing authorisation holder: MERCK
- Local brand name: LERITINE
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Adopol on 15 August 1957
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 15 August 1957; FDA has authorised it.
MERCK holds the US marketing authorisation.