FDA — authorised 12 January 1966
- Application: NDA016199
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CORTENEMA
- Indication: ENEMA — RECTAL
- Status: approved
🇺🇸 Cortenema in United States
FDA authorised Cortenema on 12 January 1966
Marketing authorisations
FDA
- Status: approved
Cortenema 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 Cortenema approved in United States?
Yes. FDA authorised it on 12 January 1966; FDA has authorised it.
Who is the marketing authorisation holder for Cortenema in United States?
ANI PHARMS holds the US marketing authorisation.