Last Updated: June 9, 2026

Details for New Drug Application (NDA): 090255

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NDA 090255 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 090255

Tradename:	HYDRALAZINE HYDROCHLORIDE
Applicant:	Invagen Pharms
Ingredient:	hydralazine hydrochloride
Patents:	0

Pharmacology for NDA: 090255

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 090255

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 090255

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	090255	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-205	43353-205-05	4200 TABLET in 1 BOTTLE (43353-205-05)
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	090255	ANDA	Exelan Pharmaceuticals Inc.	76282-309	76282-309-01	100 TABLET in 1 BOTTLE (76282-309-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 15, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Dec 15, 2008	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Dec 15, 2008	TE:		RLD:	No

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