Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 206143

Expand all

CORLANOR (IVABRADINE HYDROCHLORIDE)
EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: IVABRADINE HYDROCHLORIDE
Proprietary Name: CORLANOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N206143
Product Number: 001
Approval Date: Apr 15, 2015
Applicant Holder Full Name: AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CORLANOR (IVABRADINE HYDROCHLORIDE)
EQ 7.5MG BASE
Marketing Status: Prescription

Active Ingredient: IVABRADINE HYDROCHLORIDE
Proprietary Name: CORLANOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 7.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N206143
Product Number: 002
Approval Date: Apr 15, 2015
Applicant Holder Full Name: AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information