FDA — authorised 27 December 1976
- Application: ANDA085303
- Marketing authorisation holder: ROCHE
- Local brand name: ENDEP
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Endep in United States
FDA authorised Endep on 27 December 1976
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA083639
- Marketing authorisation holder: ROCHE
- Local brand name: ENDEP
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085749
- Marketing authorisation holder: ROCHE
- Local brand name: ENDEP
- Indication: CONCENTRATE — ORAL
- Status: approved
Endep 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 Endep approved in United States?
Yes. FDA authorised it on 27 December 1976; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Endep in United States?
ROCHE holds the US marketing authorisation.