FDA — authorised 23 February 2022
- Application: ANDA212025
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: APOMORPHINE HYDROCHLORIDE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 APL-130277 in United States
FDA authorised APL-130277 on 23 February 2022
Marketing authorisations
FDA — authorised 3 February 2025
- Application: NDA214056
- Marketing authorisation holder: MDD US
- Local brand name: ONAPGO
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Other Neurology approved in United States
Frequently asked questions
Is APL-130277 approved in United States?
Yes. FDA authorised it on 23 February 2022; FDA authorised it on 3 February 2025.
Who is the marketing authorisation holder for APL-130277 in United States?
TP ANDA HOLDINGS holds the US marketing authorisation.