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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206143
Company: AMGEN INC

Medication Guide

Products on NDA 206143

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206143

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206143Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206143Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206143Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2021	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206143Orig1s008;209964Orig1s002ltr.pdf
05/13/2019	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206143s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206143Orig1s007ltr.pdf
01/10/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206143Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206143Orig1s002ltr.pdf
05/05/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 206143

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2021	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lblrpl.pdf
08/04/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lblrpl.pdf
05/13/2019	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206143s007lbl.pdf
05/13/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206143s007lbl.pdf
01/10/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206143Orig1s002lbl.pdf
04/15/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206143Orig1s000lbl.pdf

Therapeutic Equivalents for NDA 206143

CORLANOR

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	Yes	AB	206143	AMGEN INC
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	213366	ANNORA PHARMA
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	213442	ZYDUS PHARMS

TABLET;ORAL; EQ 7.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	206143	AMGEN INC
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET;ORAL	Prescription	No	AB	213366	ANNORA PHARMA
IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET;ORAL	Prescription	No	AB	213442	ZYDUS PHARMS

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