ANDA 202016

NOVAST LABS

FDA Drug Application

Application #202016

Application Sponsors

ANDA 202016

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG;0.02MG

0

MELAMISA

DROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

ORIG

1

AP

2016-01-26

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202016
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELAMISA","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.02MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-01-26
        )

)