FDA — authorised 12 September 1988
- Application: ANDA071745
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 PRAZOSIN HYDROCHLORIDE in United States
FDA authorised PRAZOSIN HYDROCHLORIDE on 12 September 1988 · 775 US adverse-event reports
Marketing authorisations
FDA — authorised 11 January 1989
- Application: ANDA072352
- Marketing authorisation holder: WATSON LABS
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 January 1989
- Application: ANDA072609
- Marketing authorisation holder: WATSON LABS
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 January 1989
- Application: ANDA072333
- Marketing authorisation holder: WATSON LABS
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 1989
- Application: ANDA072573
- Marketing authorisation holder: MYLAN
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 1989
- Application: ANDA072575
- Marketing authorisation holder: MYLAN
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 1989
- Application: ANDA072574
- Marketing authorisation holder: MYLAN
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 March 1989
- Application: ANDA072706
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 March 1989
- Application: ANDA072705
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 March 1989
- Application: ANDA072707
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 April 1989
- Application: ANDA072577
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 January 1992
- Application: NDA019775
- Marketing authorisation holder: PFIZER
- Local brand name: MINIPRESS XL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 December 2021
- Application: ANDA214608
- Marketing authorisation holder: GRANULES
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 October 2022
- Application: ANDA213406
- Marketing authorisation holder: APPCO
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 December 2022
- Application: ANDA215697
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 March 2023
- Application: ANDA217268
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 31 March 2023
- Application: ANDA213052
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 3 January 2024
- Application: ANDA214083
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 September 2024
- Application: ANDA216727
- Marketing authorisation holder: MSN
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072783
- Marketing authorisation holder: AM THERAP
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072992
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072991
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072782
- Marketing authorisation holder: AM THERAP
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072784
- Marketing authorisation holder: AM THERAP
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA072921
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: PRAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- 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: 775
Most-reported reactions
- Fatigue — 99 reports (12.77%)
- Product Dose Omission Issue — 94 reports (12.13%)
- Off Label Use — 92 reports (11.87%)
- Abdominal Pain — 84 reports (10.84%)
- Drug Ineffective — 79 reports (10.19%)
- Nausea — 76 reports (9.81%)
- Headache — 67 reports (8.65%)
- Dyspnoea — 62 reports (8%)
- Pain — 62 reports (8%)
- Diarrhoea — 60 reports (7.74%)
PRAZOSIN 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 PRAZOSIN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 12 September 1988; FDA authorised it on 11 January 1989; FDA authorised it on 11 January 1989.
Who is the marketing authorisation holder for PRAZOSIN HYDROCHLORIDE in United States?
TEVA PHARMS holds the US marketing authorisation.