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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090527

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NDA 090527 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Adrastea Pharma, Am Regent, Eugia Pharma, Fresenius Kabi Usa, Hikma, Navinta Llc, Norvium Bioscience, 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, Macleods Pharms Ltd, Mutual Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms Inc, Strides Pharma, Superpharm, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, and Mylan, and is included in ninety-five NDAs. It is available from forty-two 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 090527

Tradename:	HYDRALAZINE HYDROCHLORIDE
Applicant:	Glenmark Pharms Ltd
Ingredient:	hydralazine hydrochloride
Patents:	0

Pharmacology for NDA: 090527

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 090527

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 090527

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	090527	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-341	68462-341-01	100 TABLET in 1 BOTTLE (68462-341-01)
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	090527	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-341	68462-341-05	500 TABLET in 1 BOTTLE (68462-341-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 29, 2009	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 29, 2009	TE:	AA	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 29, 2009	TE:	AA	RLD:	No

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