NDA 214120

CELGENE CORP

FDA Drug Application

Application #214120

Documents

• Label: 2020-09-01
• Letter: 2020-09-02
• Review: 2021-02-02
• Letter: 2022-01-11
• Label: 2022-01-11

Application Sponsors

NDA 214120

CELGENE CORP

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	200MG	0	ONUREG	AZACITIDINE
002	TABLET; ORAL	300MG	0	ONUREG	AZACITIDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2020-09-01

PRIORITY

Submissions Property Types

ORIG

1

Null

40

CDER Filings

CELGENE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214120
            [companyName] => CELGENE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONUREG","activeIngredients":"AZACITIDINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ONUREG","activeIngredients":"AZACITIDINE","strength":"300MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214120s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214120s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)