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Serving leading biopharmaceutical companies globally:

US Army
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Argus Health

Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200815

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NDA 200815 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 200815
Applicant:Vintage Pharms Llc
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200815
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 200815
Suppliers and Packaging for NDA: 200815
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 200815 ANDA Qualitest Pharmaceuticals 0603-3581 N 0603-3581-28
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 200815 ANDA Qualitest Pharmaceuticals 0603-3581 N 0603-3581-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Oct 28, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Oct 28, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 28, 2011TE:ABRLD:No

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