Application Sponsors
ANDA 201675 | 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
N/A; Not Applicable | ORIG | 1 | AP | 2014-12-19 | |
LABELING; Labeling | SUPPL | 5 | AP | 2018-08-14 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2018-08-14 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 5 | Null | 7 |
SUPPL | 6 | Null | 15 |
TE Codes
001 | Prescription | AB1 |
002 | Prescription | AB1 |
003 | Prescription | AB1 |
004 | Prescription | AB1 |
005 | Prescription | AB1 |
CDER Filings
MYLAN TECHNOLOGIES
cder:Array
(
[0] => Array
(
[ApplNo] => 201675
[companyName] => MYLAN TECHNOLOGIES
[docInserts] => ["",""]
[products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.025MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.0375MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.05MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.075MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.1MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/19\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/14\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/14\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-08-14
)
)