FDA — authorised 5 March 1954
- Application: NDA009193
- Marketing authorisation holder: MERCK
- Local brand name: COGENTIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cogentin in United States
FDA authorised Cogentin on 5 March 1954
Marketing authorisations
FDA — authorised 21 December 1959
- Application: NDA012015
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: COGENTIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Cogentin 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 Cogentin approved in United States?
Yes. FDA authorised it on 5 March 1954; FDA authorised it on 21 December 1959; FDA has authorised it.
Who is the marketing authorisation holder for Cogentin in United States?
MERCK holds the US marketing authorisation.