ANDA 205948

LUPIN LTD

FDA Drug Application

Application #205948

Application Sponsors

ANDA 205948

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

0

TYDEMY

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-12

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205948
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TYDEMY","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM","strength":"3MG,N\/A;0.03MG,N\/A;0.451MG,0.451MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-12
        )

)