FDA — authorised 1 April 2005
- Application: NDA021615
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: RAZADYNE ER
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Galantamine-CR in United States
FDA authorised Galantamine-CR on 1 April 2005
Marketing authorisation
Other Neurology approved in United States
Frequently asked questions
Is Galantamine-CR approved in United States?
Yes. FDA authorised it on 1 April 2005.
Who is the marketing authorisation holder for Galantamine-CR in United States?
JANSSEN PHARMS holds the US marketing authorisation.