FDA — authorised 17 August 1978
- Application: NDA018044
- Marketing authorisation holder: ESJAY PHARMA
- Status: supplemented
🇺🇸 Vitamin D3 as "BABY D3" in United States
FDA authorised Vitamin D3 as "BABY D3" on 17 August 1978
Marketing authorisations
FDA — authorised 12 October 2001
- Application: ANDA075765
- Marketing authorisation holder: TEVA
- Status: supplemented
FDA — authorised 27 March 2006
- Application: ANDA076917
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 23 January 2009
- Application: NDA022087
- Marketing authorisation holder: GALDERMA LABS LP
- Status: approved
FDA — authorised 21 February 2019
- Application: ANDA204556
- Marketing authorisation holder: SUN PHARM
- Status: approved
Frequently asked questions
Is Vitamin D3 as "BABY D3" approved in United States?
Yes. FDA authorised it on 17 August 1978; FDA authorised it on 12 October 2001; FDA authorised it on 27 March 2006.
Who is the marketing authorisation holder for Vitamin D3 as "BABY D3" in United States?
ESJAY PHARMA holds the US marketing authorisation.