FDA — authorised 12 July 2017
- Application: ANDA205927
- Marketing authorisation holder: MYLAN
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 P2Y12 in United States
FDA authorised P2Y12 on 12 July 2017
Marketing authorisations
FDA — authorised 16 October 2017
- Application: ANDA205888
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2017
- Application: ANDA205897
- Marketing authorisation holder: PANACEA
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2018
- Application: ANDA205987
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 2018
- Application: ANDA205913
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 January 2019
- Application: ANDA206021
- Marketing authorisation holder: HEC PHARM
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2020
- Application: ANDA205926
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2023
- Application: ANDA205930
- Marketing authorisation holder: LUPIN
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
P2Y12 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is P2Y12 approved in United States?
Yes. FDA authorised it on 12 July 2017; FDA authorised it on 16 October 2017; FDA authorised it on 16 October 2017.
Who is the marketing authorisation holder for P2Y12 in United States?
MYLAN holds the US marketing authorisation.