FDA — authorised 7 April 1970
- Status: approved
🇺🇸 Dalmane in United States
FDA authorised Dalmane on 7 April 1970
Marketing authorisations
FDA — authorised 7 April 1970
- Application: NDA016721
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: DALMANE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 June 1993
- Application: ANDA072368
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
FDA — authorised 17 July 1998
- Application: ANDA072369
- Marketing authorisation holder: CHARTWELL RX
- Indication: Manufacturing (CMC)
- Status: approved
Dalmane in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Dalmane approved in United States?
Yes. FDA authorised it on 7 April 1970; FDA authorised it on 7 April 1970; FDA authorised it on 23 June 1993.
Who is the marketing authorisation holder for Dalmane in United States?
Marketing authorisation holder not available in our data.