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Farmers Insurance
Chinese Patent Office
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Generated: May 23, 2018

DrugPatentWatch Database Preview

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 one supplier. 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 twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
Summary for 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, Inc. 24338-010 N 24338-010-12
BIDIL hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 020727 NDA Arbor Pharmaceuticals, Inc. 24338-010 N 24338-010-18

Profile for product number 001

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

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Cipla
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QuintilesIMS
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