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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 203845

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NDA 203845 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 203845

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

Pharmacology for NDA: 203845

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 203845

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 203845

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	203845	ANDA	Coupler LLC	67046-1517	67046-1517-3	30 TABLET in 1 BLISTER PACK (67046-1517-3)
HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	203845	ANDA	Cadila Pharmaceuticals Limited	71209-016	71209-016-05	100 TABLET in 1 BOTTLE (71209-016-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Sep 18, 2014	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 18, 2014	TE:	AA	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 18, 2014	TE:	AA	RLD:	No

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