ANDA 205049

MYLAN LABS LTD

FDA Drug Application

Application #205049

Documents

• Letter: 2016-06-01
• Label: 2016-06-01

Application Sponsors

ANDA 205049

MYLAN LABS LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.01MG,0.01MG;1MG,N/A

0

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-05-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-11-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205049
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.01MG,0.01MG;1MG,N\/A","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/31\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205049Orig1lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/31\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205049Orig1lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205049Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/20\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Proprietary Name Change, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/20\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-20
        )

)