NDA 206143

AMGEN INC

FDA Drug Application

Application #206143

Documents

• Letter: 2015-04-16
• Label: 2015-04-16
• Review: 2015-11-20
• Label: 2017-01-11
• Letter: 2017-01-19
• Medication Guide: 2017-01-19
• Label: 2019-05-13
• Medication Guide: 2019-05-14
• Letter: 2019-05-15
• Pediatric Written Request: 1900-01-01
• Pediatric Amendment 1: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric CDTL Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2021-08-05
• Letter: 2021-08-06
• Medication Guide: 2021-08-18

Application Sponsors

NDA 206143

AMGEN INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 5MG BASE	1	CORLANOR	IVABRADINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 7.5MG BASE	1	CORLANOR	IVABRADINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-04-15	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2017-01-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-05-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-08-04	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15
SUPPL	7	Null	31
SUPPL	8	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206143
            [companyName] => AMGEN INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/206143s007lbl.pdf#page=24"]
            [products] => [{"drugName":"CORLANOR","activeIngredients":"IVABRADINE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"CORLANOR","activeIngredients":"IVABRADINE HYDROCHLORIDE","strength":"EQ 7.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/13\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206143s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206143s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206143Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206143Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/15\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206143Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206143Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206143Orig1s000TOC.cfm\"}]","notes":">"}]
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            [actionDate] => 2019-05-13
        )

)