NDA 206088

CELGENE CORP

FDA Drug Application

Application #206088

Documents

• Label: 2014-09-26
• Summary Review: 2015-04-06
• Letter: 2014-09-24
• Review: 2015-04-06

Application Sponsors

NDA 206088

CELGENE CORP

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG	2	OTEZLA	APREMILAST
002	TABLET;ORAL	20MG	2	OTEZLA	APREMILAST
003	TABLET;ORAL	30MG	2	OTEZLA	APREMILAST

FDA Submissions

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

ORIG

1

AP

2014-09-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	TBD
002	Prescription	TBD
003	Prescription	TBD

CDER Filings

CELGENE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206088
            [companyName] => CELGENE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"OTEZLA","activeIngredients":"APREMILAST","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"OTEZLA","activeIngredients":"APREMILAST","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"OTEZLA","activeIngredients":"APREMILAST","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"09\/23\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206088s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/23\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206088s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/206088Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206088Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206088Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2014-09-23
        )

)