FDA
- Application: ANDA219403
- Marketing authorisation holder: ZENARA PHARMA PRIVATE LTD
- Local brand name: CENOBAMATE
- Indication: TABLET
- Status: approved
🇺🇸 YKP3089 in United States
YKP3089 (YKP3089) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA219473
- Marketing authorisation holder: AUROBINDO PHARMA LIMITED
- Local brand name: CENOBAMATE
- Indication: TABLET
- Status: approved
YKP3089 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is YKP3089 approved in United States?
Yes. FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for YKP3089 in United States?
ZENARA PHARMA PRIVATE LTD holds the US marketing authorisation.