ANDA 200910

MYLAN TECHNOLOGIES

FDA Drug Application

Application #200910

Documents

• Review: 2017-06-28

Application Sponsors

ANDA 200910

MYLAN TECHNOLOGIES

Marketing Status

• Prescription: 001

Application Products

001

FILM, EXTENDED RELEASE;TRANSDERMAL

0.035MG/24HR;0.15MG/24HR

0

XULANE

ETHINYL ESTRADIOL; NORELGESTROMIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-04-16
LABELING; Labeling	SUPPL	3	AP	2017-07-14	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-04-24	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-12-31	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	14	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MYLAN TECHNOLOGIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200910
            [companyName] => MYLAN TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"XULANE","activeIngredients":"ETHINYL ESTRADIOL; NORELGESTROMIN","strength":"0.035MG\/24HR;0.15MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/16\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/200910Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/31\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/09\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/14\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/14\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-12-31
        )

)