FDA — authorised 22 December 2004
- Marketing authorisation holder: WARNER CHILCOTT LLC
- Status: approved
🇺🇸 Enablex in United States
FDA authorised Enablex on 22 December 2004
Marketing authorisations
FDA — authorised 22 December 2004
- Application: NDA021513
- Marketing authorisation holder: ABBVIE
- Local brand name: ENABLEX
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 July 2017
- Application: ANDA207302
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DARIFENACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Enablex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Urology approved in United States
Frequently asked questions
Is Enablex approved in United States?
Yes. FDA authorised it on 22 December 2004; FDA authorised it on 22 December 2004; FDA authorised it on 28 July 2017.
Who is the marketing authorisation holder for Enablex in United States?
WARNER CHILCOTT LLC holds the US marketing authorisation.