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Last Updated: October 20, 2020

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Hydralazine hydrochloride - Generic Drug Details

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What are the generic drug sources for hydralazine hydrochloride and what is the scope of patent protection?

Hydralazine hydrochloride is the generic ingredient in twenty-seven branded drugs marketed by Novartis, Abraxis Pharm, Akorn, Am Regent, Fresenius Kabi Usa, Mylan Institutional, Navinta Llc, Smith And Nephew, Solopak, Teva Parenteral, Xgen Pharms, Teva, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Anda Repository, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, Par Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms Inc, Strides Pharma, Superpharm, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, Sandoz, Sun Pharm Industries, Lederle, and Arbor Pharms Llc, and is included in one hundred and twenty NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for hydralazine hydrochloride. Thirty-five suppliers are listed for this compound.

Drug Prices for hydralazine hydrochloride

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Recent Clinical Trials for hydralazine hydrochloride

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SponsorPhase
Hamilton Health Sciences CorporationPhase 2
Brigham and Women's HospitalPhase 2
University of MichiganPhase 2

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Pharmacology for hydralazine hydrochloride
Medical Subject Heading (MeSH) Categories 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
Ivax Pharms HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 088357-001 Apr 10, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 087609-001 Feb 8, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Pliva HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088467-001 May 1, 1984 AA RX No Yes   Start Trial   Start Trial   Start Trial
Pliva HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 089098-001 Dec 18, 1985 AA RX No Yes   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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