FDA — authorised 11 January 1941
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Drisdol in United States
FDA authorised Drisdol on 11 January 1941
Marketing authorisations
FDA — authorised 19 June 1975
- Application: NDA003444
- Marketing authorisation holder: ESJAY PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 28 August 1996
- Application: ANDA080704
- Marketing authorisation holder: BIONPHARMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 20 May 2009
- Application: ANDA040833
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 3 August 2010
- Application: ANDA090455
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Status: approved
FDA — authorised 7 December 2018
- Application: ANDA204276
- Marketing authorisation holder: PURACAP PHARM LLC
- Status: approved
Drisdol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Drisdol approved in United States?
Yes. FDA authorised it on 11 January 1941; FDA authorised it on 19 June 1975; FDA authorised it on 28 August 1996.
Who is the marketing authorisation holder for Drisdol in United States?
SANOFI AVENTIS US holds the US marketing authorisation.