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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 202170


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NDA 202170 describes FELODIPINE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Generics, Heritage Pharms, Jubilant Generics, Mylan, Orbion Pharms, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Vintage Pharms Llc, 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 202170
Tradename:FELODIPINE
Applicant:Torrent Pharms Ltd
Ingredient:felodipine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202170
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 202170
Suppliers and Packaging for NDA: 202170
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 202170 ANDA Torrent Pharmaceuticals Limited 13668-132 13668-132-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-132-01)
FELODIPINE felodipine TABLET, EXTENDED RELEASE;ORAL 202170 ANDA Torrent Pharmaceuticals Limited 13668-132 13668-132-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-132-05)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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