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Last Updated: November 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089097

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NDA 089097 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Akorn, Fresenius Kabi Usa, Luitpold, Mylan Institutional, Navinta Llc, Smith And Nephew, Solopak, Teva Parenteral, X-gen Pharms Inc, 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, and Ivax Pharms, and is included in ninety-two NDAs. It is available from forty-one 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 089097
Tradename:HYDRALAZINE HYDROCHLORIDE
Applicant:Pliva
Ingredient:hydralazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089097
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 089097
Suppliers and Packaging for NDA: 089097
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 089097 ANDA Teva Pharmaceuticals USA, Inc. 50111-398 50111-398-01 100 TABLET in 1 BOTTLE (50111-398-01)
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 089097 ANDA Teva Pharmaceuticals USA, Inc. 50111-398 50111-398-03 1000 TABLET in 1 BOTTLE (50111-398-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 18, 1985TE:AARLD:No

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