Data updated: Mar 10, 2026
HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE
Approved 1974-08-05
45
Indications
--
Phase 3 Trials
51
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1974-08-05
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
Companies
MUTUAL PHARM IMPAX LABS WATSON LABS SOLOPAK QUANTUM PHARMICS PLIVA ALKEM LABS LTD RISING UPSHER SMITH LABS IVAX SUB TEVA PHARMS STRIDES PHARMA INTL ASCOT Teva CHARTWELL RX SCIEGEN PHARMS PUREPAC PHARM SUPERPHARM HALSEY Fresenius Kabi HERITAGE PHARMS INC HERITAGE Hikma TP ANDA HOLDINGS PHARMOBEDIENT KINDOS USL PHARMA CADILA PHARMS LTD MACLEODS PHARMS LTD VANGARD GLENMARK PHARMS LTD AM REGENT VITARINE SMITH AND NEPHEW INVAGEN PHARMS STRIDES PHARMA ABRAXIS PHARM NAVINTA LLC HETERO LABS LTD III EUGIA PHARMA Baxter
Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Website: ↗
HYDRALAZINE HYDROCHLORIDE Approval History
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What HYDRALAZINE HYDROCHLORIDE Treats
45 FDA approvalsOriginally approved for its first indication in 1974 . Covers 45 distinct patient populations.
- Other (45)
Other
(45 approvals)- • Approved indication (Aug 1974)
- • Approved indication (Nov 1974)
- • Approved indication (Sep 1975)
- • Approved indication (Sep 1975)
- • Approved indication (Feb 1976)
- • Approved indication (Aug 1976)
- • Approved indication (Nov 1976)
- • Approved indication (Apr 1977)
- • Approved indication (Oct 1978)
- • Approved indication (Feb 1980)
- • Approved indication (Mar 1982)
- • Approved indication (May 1982)
- • Approved indication (Oct 1982)
- • Approved indication (Sep 1983)
- • Approved indication (May 1984)
- • Approved indication (Aug 1984)
- • Approved indication (Feb 1985)
- • Approved indication (Apr 1985)
- • Approved indication (Dec 1985)
- • Approved indication (May 1986)
- • Approved indication (Jul 1986)
- • Approved indication (Sep 1994)
- • Approved indication (Jun 1997)
- • Approved indication (Feb 2000)Letter
- • Approved indication (Mar 2001)Letter
- • Approved indication (Sep 2008)
- • Approved indication (Dec 2008)
- • Approved indication (Apr 2009)
- • Approved indication (May 2009)
- • Approved indication (Feb 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Dec 2012)
- • Approved indication (Mar 2013)
- • Approved indication (Mar 2013)
- • Approved indication (May 2013)
- • Approved indication (Sep 2014)
- • Approved indication (Jun 2015)Letter
- • Approved indication (Apr 2016)
- • Approved indication (May 2017)
- • Approved indication (Jul 2018)
- • Approved indication (Dec 2020)
- • Approved indication (Feb 2023)
- • Approved indication (Aug 2024)
- • Approved indication (Jun 2025) New
- • Approved indication (Jul 2025) New
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HYDRALAZINE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.