Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 500MCG | 0 | ROFLUMILAST | ROFLUMILAST |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-07-13 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-12-22 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
MYLAN
cder:Array
(
[0] => Array
(
[ApplNo] => 208257
[companyName] => MYLAN
[docInserts] => ["",""]
[products] => [{"drugName":"ROFLUMILAST","activeIngredients":"ROFLUMILAST","strength":"500MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/13\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208257Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-07-13
)
)