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Details for New Drug Application (NDA): 040388

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NDA 040388 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Hetero Labs Ltd Iii, Watson Labs, Mutual Pharm, Vangard, X-gen Pharms Inc, Ascot, Mylan, Solopak, Smith And Nephew, Halsey, Impax Labs, Glenmark Pharms Ltd, Frontida Biopharm, Akorn, Abraxis Pharm, Luitpold, Par Pharm, Alkem Labs Ltd, Ivax Sub Teva Pharms, Navinta Llc, West Ward, Sandoz, Heritage Pharms Inc, Cadila Pharms Ltd, Tg United Labs, Actavis Elizabeth, Usl Pharma, Quantum Pharmics, Invagen Pharms, Pliva, Strides Pharma, Teva Parenteral, Purepac Pharm, Actavis Grp Ptc, Mylan Institutional, Superpharm, Fresenius Kabi Usa, Vitarine, Solvay, and Ivax Pharms, and is included in ninety NDAs. It is available from thirty-nine suppliers. Additional details are available on the HYDRALAZINE HYDROCHLORIDE profile page.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are nineteen drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for NDA: 040388

Fresenius Kabi Usa
hydralazine hydrochloride
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 040388

Physiological EffectArteriolar Vasodilation

Suppliers and Packaging for NDA: 040388

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydralazine hydrochloride
INJECTABLE;INJECTION 040388 ANDA General Injectables & Vaccines, Inc 52584-614 52584-614-01 1 VIAL in 1 BAG (52584-614-01) > 1 mL in 1 VIAL
hydralazine hydrochloride
INJECTABLE;INJECTION 040388 ANDA Cardinal Health 55154-9367 55154-9367-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9367-5) > 1 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Mar 13, 2001TE:APRLD:No

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