ANDA 202014

NOVAST LABS

FDA Drug Application

Application #202014

Application Sponsors

ANDA 202014

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.35MG

0

NORETHINDRONE

NORETHINDRONE

FDA Submissions

ORIG

1

AP

2013-09-13

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB1

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202014
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE","activeIngredients":"NORETHINDRONE","strength":"0.35MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/29\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2014-08-29
        )

)