FDA — authorised 2 August 2006
- Application: NDA021881
- Marketing authorisation holder: SALIX PHARMS
- Indication: Labeling
- Status: approved
🇺🇸 Ascorbate in United States
FDA authorised Ascorbate on 2 August 2006
Marketing authorisations
FDA — authorised 25 January 2012
- Application: ANDA090145
- Marketing authorisation holder: NOVEL LABS INC
- Indication: Labeling
- Status: approved
FDA — authorised 8 September 2023
- Application: NDA209381
- Marketing authorisation holder: SALIX
- Indication: Labeling
- Status: approved
Ascorbate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Ascorbate approved in United States?
Yes. FDA authorised it on 2 August 2006; FDA authorised it on 25 January 2012; FDA authorised it on 8 September 2023.
Who is the marketing authorisation holder for Ascorbate in United States?
SALIX PHARMS holds the US marketing authorisation.