Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 250MG/50ML (5MG/ML) | 1 | ARRANON | NELARABINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2005-10-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2009-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2012-02-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2015-06-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-07-03 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-11-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2019-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2019-08-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 10 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 14 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 7 |
TE Codes
CDER Filings
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