Documents
Application Sponsors
NDA 205582 | SUN PHARMA GLOBAL | |
Marketing Status
Application Products
001 | POWDER;INTRAVENOUS | 50MG/VIAL | 1 | DECITABINE | DECITABINE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2014-01-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2016-03-16 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2019-05-22 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2020-02-03 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2020-05-21 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2020-09-16 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 0 |
SUPPL | 9 | Null | 7 |
SUPPL | 12 | Null | 6 |
SUPPL | 14 | Null | 6 |
SUPPL | 15 | Null | 6 |
CDER Filings
SUN PHARMA GLOBAL
cder:Array
(
[0] => Array
(
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[docInserts] => ["",""]
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[supplements] => [{"actionDate":"09\/16\/2020","submission":"SUPPL-15","supplementCategories":"Labeling, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205582s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205582Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"05\/21\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205582s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205582Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"02\/03\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205582s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205582Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"05\/22\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205582s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205582Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"03\/16\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/14\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-09-16
)
)