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Serving leading biopharmaceutical companies globally:

Colorcon
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Federal Trade Commission
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Cerilliant

Generated: December 11, 2017

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-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 075896

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075896

Ingredient-typeDihydropyridines
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 50090-1125-0 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-1125-0)
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 075896 ANDA Sun Pharmaceutical Industries, Inc. 53489-368 53489-368-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-368-90)

Summary for product number 001

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

Summary for product number 002

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

Summary 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 leading biopharmaceutical companies globally:

US Army
Fuji
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Covington
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Harvard Business School
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