FDA — authorised 13 April 1987
- Application: ANDA070868
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Depakene in United States
FDA authorised Depakene on 13 April 1987
Marketing authorisations
FDA — authorised 8 October 1997
- Application: ANDA073484
- Marketing authorisation holder: BIONPHARMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 January 2000
- Application: ANDA073229
- Marketing authorisation holder: CATALENT
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 13 August 2015
- Application: ANDA075379
- Marketing authorisation holder: PHARM ASSOC
- Indication: Labeling
- Status: approved
FDA — authorised 21 April 2020
- Application: ANDA075782
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
Depakene 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 Depakene approved in United States?
Yes. FDA authorised it on 13 April 1987; FDA authorised it on 8 October 1997; FDA authorised it on 27 January 2000.
Who is the marketing authorisation holder for Depakene in United States?
PHARMOBEDIENT CNSLTG holds the US marketing authorisation.