FDA — authorised 24 December 1987
- Marketing authorisation holder: MEDA PHARMS
- Status: approved
🇺🇸 Rowasa in United States
FDA authorised Rowasa on 24 December 1987
Marketing authorisations
FDA — authorised 24 December 1987
- Application: NDA019618
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Local brand name: ROWASA
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 18 December 1990
- Application: NDA019919
- Marketing authorisation holder: MEDA PHARMS
- Local brand name: ROWASA
- Indication: SUPPOSITORY — RECTAL
- Status: approved
Rowasa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Rowasa approved in United States?
Yes. FDA authorised it on 24 December 1987; FDA authorised it on 24 December 1987; FDA authorised it on 18 December 1990.
Who is the marketing authorisation holder for Rowasa in United States?
MEDA PHARMS holds the US marketing authorisation.