Details for New Drug Application (NDA): 020727

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NDA 020727 describes BIDIL, which is a drug marketed by Azurity and is included in one NDA. It is available from three suppliers. Additional details are available on the BIDIL profile page.

The generic ingredient in BIDIL is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.

Summary for 020727

Tradename:	BIDIL
Applicant:	Azurity
Ingredient:	hydralazine hydrochloride; isosorbide dinitrate
Patents:	0

Pharmacology for NDA: 020727

Physiological Effect	Arteriolar Vasodilation Vasodilation

Suppliers and Packaging for NDA: 020727

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727	NDA	Azurity	24338-010	24338-010-09	90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09)
BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727	NDA AUTHORIZED GENERIC	Wilshire Pharmaceuticals	52536-006	52536-006-09	90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	37.5MG;20MG
Approval Date:	Jun 23, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020727

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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