FDA — authorised 23 April 2014
- Application: NDA204977
- Marketing authorisation holder: OSMOTICA PHARM US
- Local brand name: OMTRYG
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 OMTRYG in United States
FDA authorised OMTRYG on 23 April 2014
Marketing authorisations
FDA
- Status: approved
OMTRYG 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 OMTRYG approved in United States?
Yes. FDA authorised it on 23 April 2014; FDA has authorised it.
Who is the marketing authorisation holder for OMTRYG in United States?
OSMOTICA PHARM US holds the US marketing authorisation.