FDA — authorised 2 November 1990
- Application: NDA019668
- Marketing authorisation holder: VIATRIS
- Status: supplemented
🇺🇸 DOXAZOSIN MESYLATE in United States
FDA authorised DOXAZOSIN MESYLATE on 2 November 1990
Marketing authorisations
FDA — authorised 18 October 2000
- Application: ANDA075646
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 2000
- Application: ANDA075609
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 2000
- Application: ANDA075453
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 2000
- Application: ANDA075580
- Marketing authorisation holder: APOTEX
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 2000
- Application: ANDA075574
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 2000
- Application: ANDA075466
- Marketing authorisation holder: GENPHARM
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 2000
- Application: ANDA075536
- Marketing authorisation holder: TEVA
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 2000
- Application: ANDA075509
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 2001
- Application: ANDA075353
- Marketing authorisation holder: TEVA
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 June 2001
- Application: ANDA075750
- Marketing authorisation holder: PLIVA
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 2004
- Application: ANDA076161
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 June 2014
- Application: ANDA202824
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2017
- Application: ANDA208719
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2018
- Application: ANDA205210
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA209013
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 March 2022
- Application: ANDA212727
- Marketing authorisation holder: RISING
- Local brand name: DOXAZOSIN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 2024
- Application: ANDA212329
- Marketing authorisation holder: UNICHEM
- Status: approved
FDA
- Status: approved
DOXAZOSIN MESYLATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DOXAZOSIN MESYLATE approved in United States?
Yes. FDA authorised it on 2 November 1990; FDA authorised it on 18 October 2000; FDA authorised it on 18 October 2000.
Who is the marketing authorisation holder for DOXAZOSIN MESYLATE in United States?
VIATRIS holds the US marketing authorisation.