FDA — authorised 16 November 2006
- Application: NDA021287
- Marketing authorisation holder: ADVANZ PHARMA
- Indication: Labeling
- Status: approved
🇺🇸 Uroxatral in United States
FDA authorised Uroxatral on 16 November 2006
Marketing authorisations
FDA — authorised 18 July 2011
- Application: ANDA079013
- Marketing authorisation holder: APOTEX INC
- Status: approved
FDA — authorised 14 November 2018
- Application: ANDA079057
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 15 September 2022
- Application: ANDA079060
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 12 November 2025
- Application: ANDA090284
- Marketing authorisation holder: INVAGEN PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Uroxatral, a medication for the treatment of benign prostatic hyperplasia (BPH), on 12 November 2025. The approval was granted to INVAGEN PHARMS through a standard expedited pathway. The application number for this approval is ANDA090284.
Uroxatral 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 Uroxatral approved in United States?
Yes. FDA authorised it on 16 November 2006; FDA authorised it on 18 July 2011; FDA authorised it on 14 November 2018.
Who is the marketing authorisation holder for Uroxatral in United States?
ADVANZ PHARMA holds the US marketing authorisation.