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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
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Dow
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US Department of Justice
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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203417

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

Summary for NDA: 203417

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

Pharmacology for NDA: 203417

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

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 Citron Pharma LLC 57237-108 57237-108-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-108-01)
FELODIPINE
felodipine
TABLET, EXTENDED RELEASE;ORAL 203417 ANDA Citron Pharma LLC 57237-109 57237-109-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-109-01)

Summary for product number 001

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

Summary for product number 002

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

Summary 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 500+ biopharmaceutical companies globally:

Medtronic
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