FDA — authorised 26 January 1953
- Application: NDA008708
- Marketing authorisation holder: ADVANZ PHARMA
- Local brand name: DIBENZYLINE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 PHENOXYBENZAMINE HYDROCHLORIDE in United States
FDA authorised PHENOXYBENZAMINE HYDROCHLORIDE on 26 January 1953 · 25 US adverse-event reports
Marketing authorisations
FDA — authorised 16 July 2012
- Application: ANDA201050
- Marketing authorisation holder: HIKMA
- Local brand name: PHENOXYBENZAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 January 2017
- Application: ANDA204522
- Marketing authorisation holder: PH HEALTH
- Local brand name: PHENOXYBENZAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 October 2020
- Application: ANDA212568
- Marketing authorisation holder: AMNEAL
- Local brand name: PHENOXYBENZAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 July 2022
- Application: ANDA215042
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
FDA — authorised 8 May 2023
- Application: ANDA215600
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: PHENOXYBENZAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 June 2023
- Application: ANDA204551
- Marketing authorisation holder: RISING
- Local brand name: PHENOXYBENZAMINE HYDROCHLORIDE
- Indication: CAPSULE — 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: 25
Most-reported reactions
- Covid-19 — 4 reports (16%)
- Urinary Tract Infection — 4 reports (16%)
- Diarrhoea — 3 reports (12%)
- Blood Pressure Decreased — 2 reports (8%)
- Constipation — 2 reports (8%)
- Dehydration — 2 reports (8%)
- Delirium — 2 reports (8%)
- Dizziness — 2 reports (8%)
- Fatigue — 2 reports (8%)
- Headache — 2 reports (8%)
PHENOXYBENZAMINE 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 PHENOXYBENZAMINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 26 January 1953; FDA authorised it on 16 July 2012; FDA authorised it on 24 January 2017.
Who is the marketing authorisation holder for PHENOXYBENZAMINE HYDROCHLORIDE in United States?
ADVANZ PHARMA holds the US marketing authorisation.