Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 10MG BASE | 0 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-01-12 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ANBISON LAB
cder:Array
(
[0] => Array
(
[ApplNo] => 205683
[companyName] => ANBISON LAB
[docInserts] => ["",""]
[products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/12\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-01-12
)
)