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
(
[ApplNo] => 205582
[companyName] => SUN PHARMA GLOBAL
[docInserts] => ["",""]
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[actionDate] => 2020-09-16
)
)