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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Covington
Colorcon
Dow
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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090365

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NDA 090365 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-one 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-two suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 090365
Tradename:FELODIPINE
Applicant:Glenmark Generics
Ingredient:felodipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090365
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 090365
Suppliers and Packaging for NDA: 090365
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 090365 ANDA Medsource Pharmaceuticals 45865-445 N 45865-445-49
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 090365 ANDA Medsource Pharmaceuticals 45865-445 N 45865-445-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Dec 17, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Dec 17, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Dec 17, 2010TE:ABRLD:No

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