ANDA 209423

JUBILANT CADISTA

FDA Drug Application

Application #209423

Application Sponsors

ANDA 209423

JUBILANT CADISTA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG;0.02MG

0

DROSPIRENONE AND ETHINYL ESTRADIOL

DROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209423
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROSPIRENONE AND ETHINYL ESTRADIOL","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.02MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-22
        )

)