Application Sponsors
Marketing Status
Application Products
001 | SUSPENSION;ORAL | 2.5MG/ML | 0 | CLOBAZAM | CLOBAZAM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-10-22 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2022-02-11 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
MYLAN
cder:Array
(
[0] => Array
(
[ApplNo] => 211259
[companyName] => MYLAN
[docInserts] => ["",""]
[products] => [{"drugName":"CLOBAZAM","activeIngredients":"CLOBAZAM","strength":"2.5MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/22\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-07-19
)
)