Application Sponsors
ANDA 200835 | WATSON LABS INC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE; ORAL | 174MG | 0 | BUPROPION HYDROBROMIDE | BUPROPION HYDROBROMIDE |
002 | TABLET, EXTENDED RELEASE; ORAL | 522MG | 0 | BUPROPION HYDROBROMIDE | BUPROPION HYDROBROMIDE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | TA | 2013-08-13 | |
Submissions Property Types
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 200835
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"BUPROPION HYDROBROMIDE","activeIngredients":"BUPROPION HYDROBROMIDE","strength":"174MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BUPROPION HYDROBROMIDE","activeIngredients":"BUPROPION HYDROBROMIDE","strength":"522MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/13\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2013-08-13
)
)