FDA — authorised 10 November 1999
- Application: NDA010721
- Marketing authorisation holder: CASPER PHARMA LLC
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Antivert in United States
FDA authorised Antivert on 10 November 1999
Marketing authorisations
FDA — authorised 15 August 2013
- Application: ANDA201451
- Marketing authorisation holder: AMNEAL PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 23 December 2019
- Application: ANDA200294
- Marketing authorisation holder: EPIC PHARMA LLC
- Indication: Labeling
- Status: approved
FDA — authorised 23 December 2019
- Application: ANDA202640
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Indication: Labeling
- Status: approved
FDA — authorised 11 August 2022
- Application: ANDA203003
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
Antivert 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 Antivert approved in United States?
Yes. FDA authorised it on 10 November 1999; FDA authorised it on 15 August 2013; FDA authorised it on 23 December 2019.
Who is the marketing authorisation holder for Antivert in United States?
CASPER PHARMA LLC holds the US marketing authorisation.