NDA 022393

CELGENE

FDA Drug Application

Application #022393

Documents

• Letter: 2009-11-13
• Letter: 2011-10-03
• Letter: 2013-06-14
• Letter: 2016-08-01
• Label: 2011-06-16
• Label: 2013-06-18
• Label: 2014-10-16
• Letter: 2011-04-15
• Letter: 2011-06-27
• Letter: 2014-10-21
• Label: 2009-11-06
• Label: 2011-04-15
• Label: 2011-09-30
• Label: 2016-07-28
• Review: 2010-01-04
• Summary Review: 2010-01-04
• Letter: 2018-12-18
• Label: 2019-07-09
• Letter: 2021-03-25
• Label: 2021-05-27
• Letter: 2021-08-02
• Label: 2021-08-03

Application Sponsors

NDA 022393

CELGENE

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

10MG/VIAL

1

ISTODAX

ROMIDEPSIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2009-11-05	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2011-06-16	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2011-09-30	STANDARD
LABELING; Labeling	SUPPL	11	AP	2013-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-09-13	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2014-10-15	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-07-27	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-11-27	STANDARD
LABELING; Labeling	SUPPL	16	TA	2020-09-24	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2021-07-30	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	14
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	16	Orphan	5
SUPPL	17	Null	15

TE Codes

001

Prescription

AP

CDER Filings

CELGENE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22393
            [companyName] => CELGENE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISTODAX","activeIngredients":"ROMIDEPSIN","strength":"10MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/27\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022393s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022393s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022393s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2014","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022393s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022393s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2011","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022393s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2011","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022393s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022393s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022393s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022393lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ISTODAX","submission":"ROMIDEPSIN","actionType":"10MG\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-11-27
        )

)