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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 089097

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NDA 089097 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Am Regent, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Kindos, Navinta Llc, Pharmobedient, Rising, Smith And Nephew, Solopak, Teva Parenteral, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, 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, Strides Pharma, Strides Pharma Intl, Superpharm, Tp Anda Holdings, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, and Mylan, and is included in ninety-seven NDAs. It is available from forty-four 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

Pharmacology for NDA: 089097

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 089097

Antihypertensive Agents
Vasodilator Agents

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	Safecor Health, LLC	48433-046	48433-046-20	100 BLISTER PACK in 1 CARTON (48433-046-20) / 1 TABLET in 1 BLISTER PACK (48433-046-01)
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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 18, 1985	TE:	AA	RLD:	No

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