ANDA 206685

MYLAN TECHNOLOGIES

FDA Drug Application

Application #206685

Documents

• Label: 2018-08-27
• Letter: 2018-09-07

Application Sponsors

ANDA 206685

MYLAN TECHNOLOGIES

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	0	ESTRADIOL	ESTRADIOL
002	FILM, EXTENDED RELEASE;TRANSDERMAL	0.0375MG/24HR	0	ESTRADIOL	ESTRADIOL
003	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	0	ESTRADIOL	ESTRADIOL
004	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	0	ESTRADIOL	ESTRADIOL
005	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	0	ESTRADIOL	ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-08-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB3
002	Prescription	AB3
003	Prescription	AB3
004	Prescription	AB3
005	Prescription	AB3

CDER Filings

MYLAN TECHNOLOGIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206685
            [companyName] => MYLAN TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.025MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.0375MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.05MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.075MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.1MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/15\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206685Orig1s000Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206685Orig1s000Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206685Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-08-15
        )

)