NDA 050794

CELGENE

FDA Drug Application

Application #050794

Documents

• Letter: 2008-08-22
• Letter: 2011-08-22
• Letter: 2014-01-14
• Label: 2004-05-19
• Label: 2011-08-24
• Label: 2014-01-13
• Review: 2004-08-05
• Letter: 2004-05-26
• Letter: 2005-07-08
• Letter: 2008-02-25
• Letter: 2011-08-22
• Letter: 2012-01-27
• Letter: 2015-12-18
• Label: 2007-02-02
• Label: 2008-08-26
• Label: 2011-08-24
• Label: 2012-01-25
• Label: 2012-12-21
• Label: 2015-12-24
• Label: 2016-08-23
• Letter: 2016-08-23
• Letter: 2018-07-25
• Label: 2018-08-02
• Label: 2020-03-19
• Letter: 2020-03-19
• Label: 2022-05-20
• Letter: 2022-05-23
• Label: 2022-09-28

Application Sponsors

NDA 050794

CELGENE

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS, SUBCUTANEOUS

100MG/VIAL

1

VIDAZA

AZACITIDINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2004-05-19	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2007-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2008-02-22	N/A
EFFICACY; Efficacy	SUPPL	11	AP	2008-08-20	PRIORITY
LABELING; Labeling	SUPPL	16	AP	2011-08-17	UNKNOWN
LABELING; Labeling	SUPPL	20	AP	2011-08-17	UNKNOWN
LABELING; Labeling	SUPPL	23	AP	2012-01-24	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2012-12-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-05-06	PRIORITY
LABELING; Labeling	SUPPL	26	AP	2014-01-10	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2015-02-23	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2015-12-17	STANDARD
LABELING; Labeling	SUPPL	29	AP	2016-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2017-01-30	STANDARD
LABELING; Labeling	SUPPL	31	AP	2018-07-20	STANDARD
LABELING; Labeling	SUPPL	32	AP	2020-03-18	STANDARD
EFFICACY; Efficacy	SUPPL	34	AP	2022-05-20	PRIORITY
LABELING; Labeling	SUPPL	35	AP	2022-09-23	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	11	Null	6
SUPPL	16	Null	7
SUPPL	20	Null	6
SUPPL	23	Null	7
SUPPL	24	Null	14
SUPPL	25	Null	14
SUPPL	26	Null	7
SUPPL	27	Null	14
SUPPL	28	Orphan	5
SUPPL	29	Null	7
SUPPL	31	Null	7
SUPPL	32	Null	31
SUPPL	34	Null	7
SUPPL	35	Null	15

TE Codes

001

Prescription

AP

CDER Filings

CELGENE

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(
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            [ApplNo] => 50794
            [companyName] => CELGENE
            [docInserts] => ["",""]
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            [labels] => [{"actionDate":"03\/18\/2020","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050794s032lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2018","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050794s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050794s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2015","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050794s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050794s026lbledt.pdf\"}]","notes":""},{"actionDate":"12\/19\/2012","submission":"SUPPL-24","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050794s024lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"01\/24\/2012","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050794s023LBL.pdf\"}]","notes":""},{"actionDate":"08\/17\/2011","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050794s016s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2011","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050794s016s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2008","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050794s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2007","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050794s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/050794lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIDAZA","submission":"AZACITIDINE","actionType":"100MG\/VIAL","submissionClassification":"POWDER;INTRAVENOUS, SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-03-18
        )

)