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Last Updated: November 22, 2024

HYDRALAZINE HYDROCHLORIDE - Generic Drug Details


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What are the generic 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, Adrastea Pharma, Am Regent, Eugia Pharma, Fresenius Kabi Usa, Hikma, Navinta Llc, Norvium Bioscience, Rising, 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, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mutual 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, Mylan, Sandoz, Sun Pharm Industries, Lederle, Azurity, I3 Pharms, and Riconpharma Llc, and is included in one hundred and twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for hydralazine hydrochloride. 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
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
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
Pliva HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088467-001 May 1, 1984 AA RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Purepac Pharm HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 088178-001 Aug 15, 1983 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mutual Pharm HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 084106-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 086962-001 Approved Prior to Jan 1, 1982 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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