Application Sponsors
ANDA 205622 | MYLAN TECHNOLOGIES | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | FILM, EXTENDED RELEASE;TRANSDERMAL | 4.6MG/24HR | 0 | RIVASTIGMINE | RIVASTIGMINE |
002 | FILM, EXTENDED RELEASE;TRANSDERMAL | 9.5MG/24HR | 0 | RIVASTIGMINE | RIVASTIGMINE |
003 | FILM, EXTENDED RELEASE;TRANSDERMAL | 13.3MG/24HR | 0 | RIVASTIGMINE | RIVASTIGMINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-06-20 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
MYLAN TECHNOLOGIES
cder:Array
(
[0] => Array
(
[ApplNo] => 205622
[companyName] => MYLAN TECHNOLOGIES
[docInserts] => ["",""]
[products] => [{"drugName":"RIVASTIGMINE","activeIngredients":"RIVASTIGMINE","strength":"4.6MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE","activeIngredients":"RIVASTIGMINE","strength":"9.5MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE","activeIngredients":"RIVASTIGMINE","strength":"13.3MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/16\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-04-16
)
)