ANDA 202770

MYLAN LABS LTD

FDA Drug Application

Application #202770

Application Sponsors

ANDA 202770

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-21

0.03MG;1.5MG

0

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-02-19
LABELING; Labeling	SUPPL	2	AP	2018-11-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-11-08	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	15
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202770
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.03MG;1.5MG","dosageForm":"TABLET;ORAL-21","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/08\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-08
        )

)