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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 201964


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NDA 201964 describes FELODIPINE, which is a drug marketed by Aurobindo Pharma Ltd, Endo Operations, Glenmark Pharms Ltd, Heritage, Jubilant Generics, Mylan, Orbion Pharms, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Wockhardt, Yiling, and Yung Shin Pharm, and is included in thirteen NDAs. It is available from fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 201964
Tradename:FELODIPINE
Applicant:Heritage
Ingredient:felodipine
Patents:0
Pharmacology for NDA: 201964
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 201964
Suppliers and Packaging for NDA: 201964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 201964 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-048 23155-048-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-048-01)
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 201964 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-048 23155-048-05 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-048-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Nov 8, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Nov 8, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Nov 8, 2013TE:ABRLD:No

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