ANDA 202970

MYLAN LABS LTD

FDA Drug Application

Application #202970

Application Sponsors

ANDA 202970

MYLAN LABS LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL-28

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

0

LEVONORGESTREL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-03-23
LABELING; Labeling	SUPPL	3	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202970
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-23
        )

)