FDA — authorised 18 July 2011
- Application: ANDA079014
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ALFUZOSIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 ALFUZOSIN HYDROCHLORIDE in United States
FDA authorised ALFUZOSIN HYDROCHLORIDE on 18 July 2011 · 936 US adverse-event reports
Marketing authorisations
FDA — authorised 18 July 2011
- Application: ANDA079013
- Marketing authorisation holder: APOTEX INC
- Local brand name: ALFUZOSIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 July 2011
- Application: ANDA079054
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: ALFUZOSIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 July 2011
- Application: ANDA079056
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ALFUZOSIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 July 2011
- Application: ANDA079057
- Marketing authorisation holder: SUN PHARM
- Local brand name: ALFUZOSIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 January 2012
- Application: ANDA090284
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: ALFUZOSIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 August 2012
- Application: ANDA090221
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: ALFUZOSIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 August 2012
- Application: ANDA079060
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ALFUZOSIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 January 2016
- Application: ANDA203192
- Marketing authorisation holder: UNICHEM
- Local brand name: ALFUZOSIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 936
Most-reported reactions
- Drug Ineffective — 124 reports (13.25%)
- Off Label Use — 104 reports (11.11%)
- Dyspnoea — 99 reports (10.58%)
- Drug Interaction — 97 reports (10.36%)
- Acute Kidney Injury — 96 reports (10.26%)
- Fatigue — 94 reports (10.04%)
- Dizziness — 85 reports (9.08%)
- Hypotension — 85 reports (9.08%)
- Diarrhoea — 77 reports (8.23%)
- Asthenia — 75 reports (8.01%)
ALFUZOSIN HYDROCHLORIDE 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 ALFUZOSIN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 18 July 2011; FDA authorised it on 18 July 2011; FDA authorised it on 18 July 2011.
Who is the marketing authorisation holder for ALFUZOSIN HYDROCHLORIDE in United States?
PHARMOBEDIENT holds the US marketing authorisation.