Application Sponsors
ANDA 078478 | SUN PHARM INDS | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | TABLET;ORAL | 5MG | 0 | TORSEMIDE | TORSEMIDE |
002 | TABLET;ORAL | 10MG | 0 | TORSEMIDE | TORSEMIDE |
003 | TABLET;ORAL | 20MG | 0 | TORSEMIDE | TORSEMIDE |
004 | TABLET;ORAL | 100MG | 0 | TORSEMIDE | TORSEMIDE |
FDA Submissions
| ORIG | 1 | AP | 2008-02-26 | |
LABELING; Labeling | SUPPL | 3 | AP | 2010-09-28 | |
CDER Filings
SUN PHARM INDS
cder:Array
(
[0] => Array
(
[ApplNo] => 78478
[companyName] => SUN PHARM INDS
[docInserts] => ["",""]
[products] => [{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)