Application Sponsors
ANDA 204285 | TEVA PHARMS USA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | EQ 100MG BASE | 0 | IMATINIB MESYLATE | IMATINIB MESYLATE |
002 | TABLET;ORAL | EQ 400MG BASE | 0 | IMATINIB MESYLATE | IMATINIB MESYLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-08-04 | |
LABELING; Labeling | SUPPL | 2 | AP | 2020-01-09 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2020-01-09 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2020-01-09 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2020-01-09 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-01-09 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 7 |
SUPPL | 7 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
TEVA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 204285
[companyName] => TEVA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/04\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/09\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/17\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-01-09
)
)