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Details for New Drug Application (NDA): 020727

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NDA 020727 describes BIDIL, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the BIDIL profile page.

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

Summary for NDA: 020727

Tradename:
BIDIL
Applicant:
Arbor Pharms Llc
Ingredient:
hydralazine hydrochloride; isosorbide dinitrate
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 020727

Ingredient-typeNitrates
Physiological EffectArteriolar 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 Arbor Pharmaceuticals 12948-001 12948-001-01 12 TABLET, FILM COATED in 1 BOTTLE (12948-001-01)
BIDIL
hydralazine hydrochloride; isosorbide dinitrate
TABLET;ORAL 020727 NDA Arbor Pharmaceuticals 12948-001 12948-001-12 180 TABLET, FILM COATED in 1 BOTTLE (12948-001-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength37.5MG;20MG
Approval Date:Jun 23, 2005TE:RLD:Yes
Patent:6,465,463Patent Expiration:Sep 8, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF HEART FAILURE
Patent:6,784,177Patent Expiration:Sep 8, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF HEART FAILURE

Expired Orange Book Patents for NDA: 020727

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc
BIDIL
hydralazine hydrochloride; isosorbide dinitrate
TABLET;ORAL020727-001Jun 23, 20054,868,179► subscribe
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