FDA — authorised 8 November 1985
- Marketing authorisation holder: ATON
- Status: approved
🇺🇸 Syprine in United States
FDA authorised Syprine on 8 November 1985
Marketing authorisations
FDA — authorised 8 November 1985
- Application: NDA019194
- Marketing authorisation holder: BAUSCH
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 16 January 2019
- Application: ANDA211251
- Marketing authorisation holder: NAVINTA LLC
- Status: approved
FDA — authorised 30 March 2021
- Application: ANDA212238
- Marketing authorisation holder: RISING
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 23 June 2022
- Application: ANDA216356
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
FDA — authorised 9 April 2025
- Application: ANDA211076
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
The FDA approved Syprine for labeling indication on April 9, 2025. This approval was granted to DR REDDYS under the standard expedited pathway. The application number for this approval is ANDA211076.
Syprine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Syprine approved in United States?
Yes. FDA authorised it on 8 November 1985; FDA authorised it on 8 November 1985; FDA authorised it on 16 January 2019.
Who is the marketing authorisation holder for Syprine in United States?
ATON holds the US marketing authorisation.