Last Updated: September 24, 2026

Hydralazine hydrochloride - Generic Drug Details


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What are the generic drug sources for hydralazine hydrochloride and what is the scope of freedom to operate?

Hydralazine hydrochloride is the generic ingredient in twenty-eight branded drugs marketed by Novartis, Abraxis Pharm, Am Regent, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Kindos, Navinta Llc, Pharmobedient, Rising, Smith And Nephew, Solopak, Teva Parenteral, Teva, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Macleods Pharms, Mutual Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms, Strides Pharma, Strides Pharma Intl, Superpharm, Tp Anda Holdings, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, Mylan, Sandoz, Sun Pharm Industries, Lederle, Azurity, I3 Pharms, and Ingenus Pharms Llc, and is included in one hundred and twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

Forty-three suppliers are listed for this compound.

Summary for hydralazine hydrochloride
Drug Prices for hydralazine hydrochloride

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Recent Clinical Trials for hydralazine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tanta UniversityPHASE1
University of CambridgePHASE4
University of AbujaPHASE4

See all hydralazine hydrochloride clinical trials

Pharmacology for hydralazine hydrochloride
Drug ClassArteriolar Vasodilator
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for hydralazine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for hydralazine hydrochloride

US Patents and Regulatory Information for hydralazine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 211010-003 Aug 21, 2024 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chartwell Rx HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088846-001 Feb 26, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 209251-003 Jul 9, 2018 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride INJECTABLE;INJECTION 203110-001 Jun 29, 2015 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Impax Labs HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 084922-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Strides Pharma HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 200770-004 Jun 25, 2019 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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