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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 040136


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NDA 040136 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Am Regent, Beowulf Asset, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan Institutional, Navinta Llc, 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 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, and Ivax Pharms, and is included in ninety-four 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 040136
Tradename:HYDRALAZINE HYDROCHLORIDE
Applicant:Am Regent
Ingredient:hydralazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040136
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 040136
Suppliers and Packaging for NDA: 040136
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride INJECTABLE;INJECTION 040136 ANDA American Regent, Inc. 0517-0901 0517-0901-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25) / 1 mL in 1 VIAL, SINGLE-DOSE
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride INJECTABLE;INJECTION 040136 ANDA Civica, Inc. 72572-265 72572-265-25 25 VIAL, SINGLE-DOSE in 1 TRAY (72572-265-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72572-265-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Jun 30, 1997TE:APRLD:No

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