FDA — authorised 4 September 2018
- Application: ANDA208390
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 D578 in United States
FDA authorised D578 on 4 September 2018
Marketing authorisations
FDA — authorised 23 January 2019
- Application: ANDA208575
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2020
- Application: ANDA208596
- Marketing authorisation holder: MSN
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2021
- Application: ANDA208597
- Marketing authorisation holder: MYLAN
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2023
- Application: ANDA208567
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 August 2024
- Application: ANDA208599
- Marketing authorisation holder: PRINSTON INC
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 May 2025
- Application: ANDA208584
- Marketing authorisation holder: APOTEX
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 May 2025
- Application: ANDA208576
- Marketing authorisation holder: ALEMBIC
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA212258
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA216187
- Marketing authorisation holder: CHANGZHOU PHARM
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA211498
- Marketing authorisation holder: TARO
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA218962
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA210219
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 March 2026
- Application: ANDA219006
- Marketing authorisation holder: ZHEJIANG JINGXIN
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is D578 approved in United States?
Yes. FDA authorised it on 4 September 2018; FDA authorised it on 23 January 2019; FDA authorised it on 7 April 2020.
Who is the marketing authorisation holder for D578 in United States?
WATSON LABS INC holds the US marketing authorisation.