FDA — authorised 9 January 1979
- Application: NDA017989
- Marketing authorisation holder: PFIZER
- Local brand name: HEMABATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Hemabate in United States
FDA authorised Hemabate on 9 January 1979
Marketing authorisations
FDA — authorised 2 July 2019
- Application: ANDA211941
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 15 June 2023
- Application: ANDA217198
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 7 August 2023
- Application: ANDA217657
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 25 January 2024
- Application: ANDA215901
- Marketing authorisation holder: ANI PHARMS
- Status: approved
FDA — authorised 3 April 2024
- Application: ANDA218013
- Marketing authorisation holder: MICRO LABS
- Status: approved
Hemabate 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 Hemabate approved in United States?
Yes. FDA authorised it on 9 January 1979; FDA authorised it on 2 July 2019; FDA authorised it on 15 June 2023.
Who is the marketing authorisation holder for Hemabate in United States?
PFIZER holds the US marketing authorisation.