Application Sponsors
ANDA 204548 | TEVA PHARMS USA | |
Marketing Status
Application Products
001 | SUSPENSION;INHALATION | 1MG/2ML | 0 | BUDESONIDE | BUDESONIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-03-08 | |
LABELING; Labeling | SUPPL | 3 | AP | 2021-03-31 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
TEVA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 204548
[companyName] => TEVA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"1MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/08\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/29\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2016-04-29
)
)