ANDA 203435

NOVAST LABS

FDA Drug Application

Application #203435

Application Sponsors

ANDA 203435

NOVAST LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	0.005MG;1MG	0	LERIBANE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
002	TABLET;ORAL	0.0025MG;0.5MG	0	LERIBANE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-06-03

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203435
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LERIBANE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.005MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LERIBANE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.0025MG;0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-03
        )

)