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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Cerilliant
Baxter
Fish and Richardson
Cantor Fitzgerald
Covington
Harvard Business School
Medtronic
Teva

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203417

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NDA 203417 describes FELODIPINE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Generics, Heritage Pharms Inc, Jubilant Generics, Mylan, Orchid Hlthcare, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Vintage Pharms Llc, and Wockhardt Ltd, and is included in eleven NDAs. It is available from nineteen suppliers. Additional details are available on the FELODIPINE profile page.

The generic ingredient in FELODIPINE is felodipine. There are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 203417
Tradename:FELODIPINE
Applicant:Aurobindo Pharma Ltd
Ingredient:felodipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203417
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 203417
Suppliers and Packaging for NDA: 203417
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 203417 ANDA Rising Health, LLC 57237-108 N 57237-108-01
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 203417 ANDA Rising Health, LLC 57237-109 N 57237-109-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Jan 17, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Jan 17, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jan 17, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
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Fuji
McKinsey
Chubb
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