FDA — authorised 3 August 1988
- Application: NDA018749
- Marketing authorisation holder: MISSION PHARMA
- Indication: Labeling
- Status: approved
FDA authorised Lithostat on 3 August 1988
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 3 August 1988.
MISSION PHARMA holds the US marketing authorisation.