FDA — authorised 12 June 1979
- Marketing authorisation holder: ODYSSEY PHARMS
- Status: approved
🇺🇸 Surmontil in United States
FDA authorised Surmontil on 12 June 1979
Marketing authorisations
FDA — authorised 12 June 1979
- Application: NDA016792
- Marketing authorisation holder: TEVA WOMENS
- Local brand name: SURMONTIL
- Indication: CAPSULE — ORAL
- Status: approved
Surmontil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Surmontil approved in United States?
Yes. FDA authorised it on 12 June 1979; FDA authorised it on 12 June 1979.
Who is the marketing authorisation holder for Surmontil in United States?
ODYSSEY PHARMS holds the US marketing authorisation.