Application Sponsors
ANDA 200831 | WATSON LABS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 10MG | 0 | EZETIMIBE | EZETIMIBE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2017-06-12 | |
Submissions Property Types
TE Codes
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 200831
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"EZETIMIBE","activeIngredients":"EZETIMIBE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-06-12
)
)