FDA — authorised 31 October 2011
- Application: ANDA090377
- Marketing authorisation holder: IMPAX LABS
- Indication: Labeling
- Status: approved
🇺🇸 Flomax in United States
FDA authorised Flomax on 31 October 2011
Marketing authorisations
FDA — authorised 9 November 2015
- Application: ANDA090931
- Marketing authorisation holder: SUN PHARM INDS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 13 June 2016
- Application: NDA022460
- Marketing authorisation holder: WAYLIS THERAP
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 26 June 2017
- Application: ANDA204645
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 July 2024
- Application: ANDA213300
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
Flomax 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 Flomax approved in United States?
Yes. FDA authorised it on 31 October 2011; FDA authorised it on 9 November 2015; FDA authorised it on 13 June 2016.
Who is the marketing authorisation holder for Flomax in United States?
IMPAX LABS holds the US marketing authorisation.