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Last Updated: January 27, 2023

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-eight branded drugs marketed by Novartis, Abraxis Pharm, Akorn, Am Regent, Beowulf Asset, Fresenius Kabi Usa, Hikma, Mylan Institutional, Navinta Llc, Smith And Nephew, Solopak, Teva Parenteral, Teva, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Anda Repository, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage Pharms, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, 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, Azurity, and Riconpharma Llc, and is included in one hundred and twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for hydralazine hydrochloride. Forty suppliers are listed for this compound.

Drug Prices for hydralazine hydrochloride

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Recent Clinical Trials for hydralazine hydrochloride

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

SponsorPhase
National Institute for Medical Research Development (NIMAD), IranPhase 3
McMaster UniversityPhase 3
Shahid Sadoughi University of Medical Sciences and Health ServicesPhase 3

See all hydralazine hydrochloride clinical trials

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
Alkem Labs Ltd HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 200737-004 Dec 7, 2012 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Rx CAM-AP-ES hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 084897-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd Iii HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 040901-002 Sep 12, 2008 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Superpharm HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088787-001 Aug 28, 1984 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 085532-002 May 24, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
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Dow
Moodys
McKinsey

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