Application Sponsors
ANDA 210017 | JUBILANT CADISTA | |
Marketing Status
Application Products
001 | TABLET;ORAL-28 | 3MG;0.03MG | 0 | DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE; ETHINYL ESTRADIOL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-09-10 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
JUBILANT CADISTA
cder:Array
(
[0] => Array
(
[ApplNo] => 210017
[companyName] => JUBILANT CADISTA
[docInserts] => ["",""]
[products] => [{"drugName":"DROSPIRENONE AND ETHINYL ESTRADIOL","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.03MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-09-10
)
)