Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 100MG BASE | 1 | GLEEVEC | IMATINIB MESYLATE |
| 002 | TABLET;ORAL | EQ 400MG BASE | 1 | GLEEVEC | IMATINIB MESYLATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2003-04-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2003-12-08 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2004-06-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2005-03-14 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2005-05-19 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2005-05-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2005-10-20 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2006-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2006-05-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2006-10-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2006-10-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2006-10-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2006-10-19 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2006-09-27 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2006-10-19 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2007-09-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 21 | AP | 2008-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2008-09-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2008-04-30 | N/A |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2008-09-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2008-12-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2009-05-27 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2009-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2009-05-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2011-04-01 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2011-04-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2012-01-31 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 2013-01-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 38 | AP | 2013-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2013-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2014-05-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 42 | AP | 2015-01-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 45 | AP | 2016-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2016-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2016-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2017-04-24 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2017-09-06 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 52 | AP | 2017-09-29 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2018-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2020-08-10 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2020-08-10 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2022-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2022-08-19 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 25 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 11 | Null | 31 |
| SUPPL | 12 | Null | 31 |
| SUPPL | 13 | Null | 31 |
| SUPPL | 14 | Null | 31 |
| SUPPL | 16 | Null | 26 |
| SUPPL | 17 | Null | 31 |
| SUPPL | 20 | Null | 41 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 49 | Orphan | 5 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 52 | Null | 6 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 56 | Null | 15 |
| SUPPL | 57 | Null | 6 |
| SUPPL | 60 | Null | 15 |
| SUPPL | 62 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
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