ANDA 207976

NOVAST LABS

FDA Drug Application

Application #207976

Application Sponsors

ANDA 207976

NOVAST LABS

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

1.5MG

0

HER STYLE

LEVONORGESTREL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-06-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207976
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HER STYLE","activeIngredients":"LEVONORGESTREL","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/16\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/16\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-06-16
        )

)