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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Fish and Richardson
Farmers Insurance
Queensland Health

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075896

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NDA 075896 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 twenty-two 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-three suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 075896
Applicant:Sun Pharm Industries
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075896
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 075896
Suppliers and Packaging for NDA: 075896
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 075896 ANDA A-S Medication Solutions 50090-1125 N 50090-1125-0
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 075896 ANDA Sun Pharmaceutical Industries, Inc. 53489-368 N 53489-368-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Nov 2, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Nov 2, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Nov 2, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Harvard Business School
Fish and Richardson

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