FDA — authorised 25 March 1998
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
🇺🇸 Detrol in United States
FDA authorised Detrol on 25 March 1998
Marketing authorisations
FDA — authorised 31 August 2015
- Application: ANDA203409
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA — authorised 19 August 2019
- Application: ANDA204562
- Marketing authorisation holder: INVENTIA HLTHCARE
- Status: approved
FDA — authorised 9 March 2020
- Application: ANDA203016
- Marketing authorisation holder: TORRENT
- Indication: Labeling
- Status: approved
FDA — authorised 19 May 2020
- Application: ANDA213397
- Marketing authorisation holder: AJANTA PHARMA LTD
- Status: approved
FDA — authorised 5 August 2020
- Application: ANDA205399
- Marketing authorisation holder: UNICHEM
- Status: approved
Detrol 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 Detrol approved in United States?
Yes. FDA authorised it on 25 March 1998; FDA authorised it on 31 August 2015; FDA authorised it on 19 August 2019.
Who is the marketing authorisation holder for Detrol in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.