NDA 209606

CELGENE CORP

FDA Drug Application

Application #209606

Documents

• Label: 2017-08-01
• Medication Guide: 2017-08-01
• Letter: 2017-08-02
• Review: 2017-08-24
• Letter: 2019-09-30
• Label: 2019-10-01
• Medication Guide: 2019-10-01
• Label: 2020-11-25
• Medication Guide: 2020-11-25
• Letter: 2020-11-27
• Letter: 2021-07-27

Application Sponsors

NDA 209606

CELGENE CORP

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 50MG BASE	1	IDHIFA	ENASIDENIB MESYLATE
002	TABLET;ORAL	EQ 100MG BASE	1	IDHIFA	ENASIDENIB MESYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-08-01	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2019-09-27	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2020-11-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2021-07-26	N/A

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	4	Null	15

CDER Filings

CELGENE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209606
            [companyName] => CELGENE CORP
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/209606s002lbl.pdf#page=16"]
            [products] => [{"drugName":"IDHIFA","activeIngredients":"ENASIDENIB MESYLATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"IDHIFA","activeIngredients":"ENASIDENIB MESYLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/27\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209606s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209606s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/01\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209606s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209606Orig1s000.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209606Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/27\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209606s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209606Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-09-27
        )

)