FDA — authorised 8 October 2008
- Application: NDA021762
- Marketing authorisation holder: ORGANON LLC
- Indication: Labeling
- Status: approved
🇺🇸 Vitamin D3 in United States
FDA authorised Vitamin D3 on 8 October 2008
Marketing authorisations
FDA — authorised 2 December 2015
- Application: NDA021265
- Marketing authorisation holder: SANDOZ CANADA INC
- Indication: Manufacturing (CMC)
- Status: approved
Vitamin D3 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 Vitamin D3 approved in United States?
Yes. FDA authorised it on 8 October 2008; FDA authorised it on 2 December 2015.
Who is the marketing authorisation holder for Vitamin D3 in United States?
ORGANON LLC holds the US marketing authorisation.