Application Sponsors
ANDA 203877 | TEVA PHARMS USA | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | INJECTABLE;INJECTION | 20MG/ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
002 | INJECTABLE;INJECTION | 80MG/4ML (20MG/ML) | 0 | DOCETAXEL | DOCETAXEL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-09-16 | |
LABELING; Labeling | SUPPL | 3 | AP | 2020-07-28 | STANDARD |
Submissions Property Types
CDER Filings
TEVA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 203877
[companyName] => TEVA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/4ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/28\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/28\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-07-28
)
)