FDA — authorised 8 November 2001
- Marketing authorisation holder: ENDO PHARMS
- Status: approved
🇺🇸 Frova in United States
FDA authorised Frova on 8 November 2001
Marketing authorisations
FDA — authorised 8 November 2001
- Application: NDA021006
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: FROVA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 2016
- Application: ANDA204730
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 6 April 2022
- Application: ANDA213891
- Marketing authorisation holder: RENATA
- Status: approved
FDA — authorised 17 May 2024
- Application: ANDA211292
- Marketing authorisation holder: AMNEAL PHARMS CO
- Indication: Labeling
- Status: approved
The FDA approved Frova for labeling indications. This approval was granted to AMNEAL PHARMS CO through a standard expedited pathway. The approval date was 2024-05-17.
Frova in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Frova approved in United States?
Yes. FDA authorised it on 8 November 2001; FDA authorised it on 8 November 2001; FDA authorised it on 11 March 2016.
Who is the marketing authorisation holder for Frova in United States?
ENDO PHARMS holds the US marketing authorisation.