ANDA 202996

NOVAST LABS

FDA Drug Application

Application #202996

Application Sponsors

ANDA 202996

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-21

0.03MG;1.5MG

0

LARIN 1.5/30

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-03-20

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202996
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LARIN 1.5\/30","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.03MG;1.5MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/20\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-03-20
        )

)