FDA — authorised 23 March 1943
- Marketing authorisation holder: ENDO PHARMS
- Status: approved
🇺🇸 Hycodan in United States
FDA authorised Hycodan on 23 March 1943
Marketing authorisations
FDA — authorised 23 March 1943
- Application: NDA005213
- Marketing authorisation holder: GENUS
- Local brand name: HYCODAN
- Indication: TABLET — ORAL
- Status: approved
Hycodan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Hycodan approved in United States?
Yes. FDA authorised it on 23 March 1943; FDA authorised it on 23 March 1943.
Who is the marketing authorisation holder for Hycodan in United States?
ENDO PHARMS holds the US marketing authorisation.