ANDA 091454

NOVAST LABS

FDA Drug Application

Application #091454

Application Sponsors

ANDA 091454

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.02MG;1MG

0

LARIN FE 1/20

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

ORIG

1

AP

2013-08-26

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91454
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LARIN FE 1\/20","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG;1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LARIN FE 1\/20","submission":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","actionType":"0.02MG;1MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)