Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET, FOR SUSPENSION;ORAL | 125MG | 1 | EXJADE | DEFERASIROX |
| 002 | TABLET, FOR SUSPENSION;ORAL | 250MG | 1 | EXJADE | DEFERASIROX |
| 003 | TABLET, FOR SUSPENSION;ORAL | 500MG | 1 | EXJADE | DEFERASIROX |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2005-11-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2007-04-20 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2007-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2008-10-02 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2009-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2009-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2010-01-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 11 | AP | 2011-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-08-10 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2012-09-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2013-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2013-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2013-05-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2013-11-01 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 2013-10-21 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2015-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2016-08-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2018-05-11 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2018-02-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2018-12-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 29 | AP | 2018-12-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2019-07-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 2019-05-24 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2020-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2023-01-17 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 14 |
| SUPPL | 19 | Orphan | 5 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 28 | Orphan | 5 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 33 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21882
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)