Application Sponsors
ANDA 210011 | STRIDES PHARMA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 200MG | 0 | ALBENDAZOLE | ALBENDAZOLE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-12-07 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2020-03-15 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 210011
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"ALBENDAZOLE","activeIngredients":"ALBENDAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/15\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-15
)
)