Application Sponsors
ANDA 203186 | MYLAN PHARMS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL | 2.5MG | 0 | ZOLMITRIPTAN | ZOLMITRIPTAN |
002 | TABLET;ORAL | 5MG | 0 | ZOLMITRIPTAN | ZOLMITRIPTAN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2013-05-14 | |
LABELING; Labeling | SUPPL | 3 | AP | 2021-10-20 | STANDARD |
Submissions Property Types
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203186
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/14\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2013-05-14
)
)