FDA — authorised 25 February 1975
- Status: approved
🇺🇸 Adasuve in United States
FDA authorised Adasuve on 25 February 1975
Marketing authorisations
FDA — authorised 13 February 1997
- Application: ANDA072062
- Marketing authorisation holder: WATSON LABS
- Indication: Labeling
- Status: approved
FDA — authorised 13 February 1997
- Application: ANDA072205
- Marketing authorisation holder: WATSON LABS
- Indication: Labeling
- Status: approved
FDA — authorised 25 November 1997
- Application: ANDA072204
- Marketing authorisation holder: WATSON LABS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 8 September 2008
- Application: ANDA072206
- Marketing authorisation holder: WATSON LABS
- Indication: Labeling
- Status: approved
FDA — authorised 26 September 2011
- Application: ANDA090695
- Marketing authorisation holder: LANNETT CO INC
- Status: approved
Adasuve 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 Adasuve approved in United States?
Yes. FDA authorised it on 25 February 1975; FDA authorised it on 13 February 1997; FDA authorised it on 13 February 1997.
Who is the marketing authorisation holder for Adasuve in United States?
Marketing authorisation holder not available in our data.