ANDA 075182

MYLAN TECHNOLOGIES

FDA Drug Application

Application #075182

Documents

• Letter: 2000-02-24
• Letter: 2006-07-21
• Review: 2000-02-24
• Letter: 2006-07-21

Application Sponsors

ANDA 075182

MYLAN TECHNOLOGIES

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	0	ESTRADIOL	ESTRADIOL
002	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	0	ESTRADIOL	ESTRADIOL
003	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	0	ESTRADIOL	ESTRADIOL
004	FILM, EXTENDED RELEASE;TRANSDERMAL	0.0375MG/24HR	0	ESTRADIOL	ESTRADIOL
005	FILM, EXTENDED RELEASE;TRANSDERMAL	0.06MG/24HR	0	ESTRADIOL	ESTRADIOL
006	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	0	ESTRADIOL	ESTRADIOL

FDA Submissions

	ORIG	1	AP	2000-02-24
LABELING; Labeling	SUPPL	2	AP	2001-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-12-23
S; Supplement	SUPPL	6	AP	2005-01-26
LABELING; Labeling	SUPPL	8	AP	2005-01-26
S; Supplement	SUPPL	9	AP	2005-01-26
LABELING; Labeling	SUPPL	11	AP	2005-01-06
LABELING; Labeling	SUPPL	13	AP	2005-01-21
LABELING; Labeling	SUPPL	14	AP	2005-10-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2006-07-20
LABELING; Labeling	SUPPL	16	AP	2006-07-20
LABELING; Labeling	SUPPL	23	AP	2009-07-09
LABELING; Labeling	SUPPL	28	AP	2014-12-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	15	Null	0
SUPPL	28	Null	7

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	AB2
004	Prescription	AB2
005	Prescription	AB
006	Prescription	AB2

CDER Filings

MYLAN TECHNOLOGIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75182
            [companyName] => MYLAN TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.1MG\/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":"0.025MG\/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":"0.06MG\/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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.1MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.075MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.025MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.0375MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.06MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.05MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)