FDA — authorised 21 December 2010
- Application: ANDA090095
- Marketing authorisation holder: BARR
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Regular water, tamsulosin, Dutasteride in United States
FDA authorised Regular water, tamsulosin, Dutasteride on 21 December 2010
Marketing authorisations
FDA — authorised 26 February 2014
- Application: ANDA202509
- Marketing authorisation holder: PH HEALTH
- Local brand name: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 November 2015
- Application: ANDA202808
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 November 2015
- Application: ANDA204705
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 November 2015
- Application: ANDA202975
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 November 2015
- Application: ANDA200899
- Marketing authorisation holder: CHARTWELL
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 November 2015
- Application: ANDA202530
- Marketing authorisation holder: RISING
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 November 2015
- Application: ANDA204262
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 November 2015
- Application: ANDA202660
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 November 2015
- Application: ANDA202204
- Marketing authorisation holder: HIKMA
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 March 2016
- Application: ANDA206373
- Marketing authorisation holder: ACELLA
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 June 2016
- Application: ANDA203241
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 October 2016
- Application: ANDA206574
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 April 2017
- Application: ANDA204376
- Marketing authorisation holder: ADAPTIS
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 October 2017
- Application: ANDA204373
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 October 2017
- Application: ANDA207935
- Marketing authorisation holder: HERITAGE PHARMS INC
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 November 2017
- Application: ANDA209909
- Marketing authorisation holder: HUMANWELL PURACAP
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 June 2018
- Application: ANDA208227
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: DUTASTERIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 July 2024
- Application: ANDA213300
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
Frequently asked questions
Is Regular water, tamsulosin, Dutasteride approved in United States?
Yes. FDA authorised it on 21 December 2010; FDA authorised it on 26 February 2014; FDA authorised it on 20 November 2015.
Who is the marketing authorisation holder for Regular water, tamsulosin, Dutasteride in United States?
BARR holds the US marketing authorisation.