FDA — authorised 28 February 2001
- Application: NDA021169
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: RAZADYNE
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Galantamine oral solution on 28 February 2001
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 28 February 2001; FDA has authorised it.
JANSSEN PHARMS holds the US marketing authorisation.