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Serving leading biopharmaceutical companies globally:

Deloitte
Julphar
Mallinckrodt
Novartis
Fish and Richardson
Accenture
QuintilesIMS
Daiichi Sankyo
Merck
Johnson and Johnson

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077169

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NDA 077169 describes ISRADIPINE, which is a drug marketed by Elite Labs Inc, Watson Labs Teva, and Mylan Pharms Inc, and is included in three NDAs. It is available from five suppliers. Additional details are available on the ISRADIPINE profile page.

The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isradipine profile page.
Summary for 077169
Tradename:ISRADIPINE
Applicant:Elite Labs Inc
Ingredient:isradipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077169
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 077169
Suppliers and Packaging for NDA: 077169
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISRADIPINE isradipine CAPSULE;ORAL 077169 ANDA Epic Pharma, LLC 42806-263 42806-263-01 100 CAPSULE in 1 BOTTLE (42806-263-01)
ISRADIPINE isradipine CAPSULE;ORAL 077169 ANDA Epic Pharma, LLC 42806-263 42806-263-05 500 CAPSULE in 1 BOTTLE (42806-263-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Apr 24, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Apr 24, 2006TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Deloitte
Novartis
US Army
McKesson
Fish and Richardson
Baxter
Boehringer Ingelheim
Mallinckrodt
Covington

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