FDA — authorised 29 April 2024
- Application: ANDA216076
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: MIDOSTAURIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 PKC412 in United States
FDA authorised PKC412 on 29 April 2024
Marketing authorisations
FDA — authorised 10 May 2024
- Application: ANDA216015
- Marketing authorisation holder: LUPIN
- Local brand name: MIDOSTAURIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA215834
- Marketing authorisation holder: LOTUS PHARM CO LTD
- Local brand name: MIDOSTAURIN
- Indication: CAPSULE — ORAL
- Status: approved
Frequently asked questions
Is PKC412 approved in United States?
Yes. FDA authorised it on 29 April 2024; FDA authorised it on 10 May 2024; FDA has authorised it.
Who is the marketing authorisation holder for PKC412 in United States?
TEVA PHARMS holds the US marketing authorisation.