NDA 208855

ELI LILLY AND CO

FDA Drug Application

Application #208855

Documents

• Label: 2018-02-26
• Letter: 2018-03-01
• Review: 2018-10-26

Application Sponsors

NDA 208855

ELI LILLY AND CO

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	50MG	2	VERZENIO	ABEMACICLIB
002	TABLET;ORAL	100MG	2	VERZENIO	ABEMACICLIB
003	TABLET;ORAL	150MG	2	VERZENIO	ABEMACICLIB
004	TABLET;ORAL	200MG	2	VERZENIO	ABEMACICLIB

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval

ORIG

1

AP

2018-02-26

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

ELI LILLY AND CO

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(
    [0] => Array
        (
            [ApplNo] => 208855
            [companyName] => ELI LILLY AND CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERZENIO","activeIngredients":"ABEMACICLIB","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"VERZENIO","activeIngredients":"ABEMACICLIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"VERZENIO","activeIngredients":"ABEMACICLIB","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"VERZENIO","activeIngredients":"ABEMACICLIB","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/26\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208855s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208855s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208855Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208855Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-02-26
        )

)