ANDA 202246

ALVOGEN

FDA Drug Application

Application #202246

Application Sponsors

ANDA 202246

ALVOGEN

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

1.5MG

0

LEVONORGESTREL

LEVONORGESTREL

FDA Submissions

	ORIG	1	AP	2015-06-05
LABELING; Labeling	SUPPL	3	AP	2016-07-06	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-02-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202246
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL","activeIngredients":"LEVONORGESTREL","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/05\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/20\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/06\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/06\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-02-20
        )

)