ANDA 090716

NOVAST LABS

FDA Drug Application

Application #090716

Application Sponsors

ANDA 090716

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.03MG;0.15MG

0

SETLAKIN

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

ORIG

1

AP

2014-09-15

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90716
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SETLAKIN","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG;0.15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SETLAKIN","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.03MG;0.15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)