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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203110


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NDA 203110 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 203110
Tradename:HYDRALAZINE HYDROCHLORIDE
Applicant:Adrastea Pharma
Ingredient:hydralazine hydrochloride
Patents:0
Pharmacology for NDA: 203110
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 203110
Suppliers and Packaging for NDA: 203110
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride INJECTABLE;INJECTION 203110 ANDA Medical Purchasing Solutions, LLC 71872-7050 71872-7050-1 1 VIAL in 1 BAG (71872-7050-1) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Jun 29, 2015TE:APRLD:No

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