Last Updated: May 11, 2026

Details for New Drug Application (NDA): 089258

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NDA 089258 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 089258

Tradename:	HYDRALAZINE HYDROCHLORIDE
Applicant:	Tp Anda Holdings
Ingredient:	hydralazine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 089258

Antihypertensive Agents
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 5, 1986	TE:		RLD:	No

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