Application Sponsors
ANDA 205682 | WATSON LABS INC | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET;ORAL | 400MG | 0 | DRONEDARONE HYDROCHLORIDE | DRONEDARONE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2015-12-31 | STANDARD |
Submissions Property Types
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205682
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"DRONEDARONE HYDROCHLORIDE","activeIngredients":"DRONEDARONE HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/31\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-12-31
)
)