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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 040901


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NDA 040901 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Adrastea Pharma, Am Regent, Eugia Pharma, Fresenius Kabi Usa, Hikma, Navinta Llc, Norvium Bioscience, Rising, Smith And Nephew, Solopak, Teva Parenteral, 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, and Mylan, and is included in ninety-five NDAs. It is available from forty-two suppliers. Additional details are available on the HYDRALAZINE HYDROCHLORIDE profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
Summary for 040901
Pharmacology for NDA: 040901
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 040901
Suppliers and Packaging for NDA: 040901
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 040901 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-7973 0615-7973-05 15 TABLET in 1 BLISTER PACK (0615-7973-05)
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 040901 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-7973 0615-7973-39 30 TABLET in 1 BLISTER PACK (0615-7973-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 12, 2008TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 12, 2008TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 12, 2008TE:AARLD:No

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