NOVAST LABS FDA Approval ANDA 091453

ANDA 091453

NOVAST LABS

FDA Drug Application

Application #091453

Application Sponsors

ANDA 091453NOVAST LABS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-280.03MG;1.5MG0LARIN FE 1.5/30ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

ORIG1AP2013-08-23

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

NOVAST LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91453
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LARIN FE 1.5\/30","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.03MG;1.5MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LARIN FE 1.5\/30","submission":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","actionType":"0.03MG;1.5MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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