FDA — authorised 20 May 2009
- Application: ANDA040833
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ERGOCALCIFEROL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Vitamin D2 in United States
FDA authorised Vitamin D2 on 20 May 2009
Marketing authorisations
FDA — authorised 29 December 2009
- Application: ANDA040865
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: ERGOCALCIFEROL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 July 2010
- Application: ANDA091004
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: ERGOCALCIFEROL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 August 2010
- Application: ANDA090455
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: ERGOCALCIFEROL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Vitamin D2 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Vitamin D2 approved in United States?
Yes. FDA authorised it on 20 May 2009; FDA authorised it on 29 December 2009; FDA authorised it on 14 July 2010.
Who is the marketing authorisation holder for Vitamin D2 in United States?
CHARTWELL RX holds the US marketing authorisation.