ANDA 203006

MYLAN LABS LTD

FDA Drug Application

Application #203006

Documents

• Letter: 2013-08-06

Application Sponsors

ANDA 203006

MYLAN LABS LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL-28

0.05MG;1MG

0

NORETHINDRONE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-08-05
LABELING; Labeling	SUPPL	2	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203006
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.05MG;1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/05\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203006Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-08-09
        )

)