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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 206143


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NDA 206143 describes CORLANOR, which is a drug marketed by Amgen Inc and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the CORLANOR profile page.

The generic ingredient in CORLANOR is ivabradine hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.
Summary for 206143
Tradename:CORLANOR
Applicant:Amgen Inc
Ingredient:ivabradine hydrochloride
Patents:4
Pharmacology for NDA: 206143
Suppliers and Packaging for NDA: 206143
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORLANOR ivabradine hydrochloride TABLET;ORAL 206143 NDA Amgen Inc 55513-800 55513-800-60 60 TABLET, FILM COATED in 1 BOTTLE (55513-800-60)
CORLANOR ivabradine hydrochloride TABLET;ORAL 206143 NDA Amgen Inc 55513-800 55513-800-99 14 TABLET, FILM COATED in 1 BOTTLE (55513-800-99)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Apr 15, 2015TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 22, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Aug 22, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Jun 12, 2027Product Flag?Substance Flag?Delist Request?Y

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