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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 040388

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NDA 040388 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 Inc, 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 040388

Tradename:	HYDRALAZINE HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	hydralazine hydrochloride
Patents:	0

Pharmacology for NDA: 040388

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 040388

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 040388

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	040388	ANDA	Henry Schein, Inc.	0404-9787	0404-9787-01	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9787-01) / 1 mL in 1 VIAL, SINGLE-DOSE
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	040388	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1376	51662-1376-1	1 mL in 1 VIAL, SINGLE-DOSE (51662-1376-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Mar 13, 2001	TE:	AP	RLD:	No

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