FDA — authorised 16 July 1975
- Status: approved
🇺🇸 Ditropan Xl in United States
FDA authorised Ditropan Xl on 16 July 1975
Marketing authorisations
FDA — authorised 7 December 2011
- Application: NDA202513
- Marketing authorisation holder: ALLERGAN
- Local brand name: GELNIQUE 3%
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 25 January 2013
- Application: NDA202211
- Marketing authorisation holder: ABBVIE
- Local brand name: OXYTROL FOR WOMEN
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 4 March 2014
- Application: ANDA090526
- Marketing authorisation holder: BARR LABS DIV TEVA
- Local brand name: OXYBUTYNIN
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
Ditropan Xl in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Ditropan Xl approved in United States?
Yes. FDA authorised it on 16 July 1975; FDA authorised it on 7 December 2011; FDA authorised it on 25 January 2013.
Who is the marketing authorisation holder for Ditropan Xl in United States?
Hisamitsu Pharmaceutical Co., Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.