NDA 209964

AMGEN INC

FDA Drug Application

Application #209964

Documents

• Label: 2019-04-22
• Medication Guide: 2019-04-22
• Letter: 2019-04-24
• Review: 2019-11-13
• Pediatric CDTL Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Label: 2021-08-05
• Letter: 2021-08-06
• Medication Guide: 2021-08-18

Application Sponsors

NDA 209964

AMGEN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML (1MG/ML)

1

CORLANOR

IVABRADINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-04-22	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2021-08-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

AMGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209964
            [companyName] => AMGEN INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/209964lbl.pdf#page=24"]
            [products] => [{"drugName":"CORLANOR","activeIngredients":"IVABRADINE","strength":"5MG\/5ML (1MG\/ML)","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/22\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209964lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209964lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209964Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209964Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-04-22
        )

)