Application Sponsors
ANDA 090642 | WATSON LABS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | TABLET;ORAL | 40MG | 0 | VALSARTAN | VALSARTAN |
002 | TABLET;ORAL | 80MG | 0 | VALSARTAN | VALSARTAN |
003 | TABLET;ORAL | 160MG | 0 | VALSARTAN | VALSARTAN |
004 | TABLET;ORAL | 320MG | 0 | VALSARTAN | VALSARTAN |
FDA Submissions
| ORIG | 1 | AP | 2015-01-05 | |
LABELING; Labeling | SUPPL | 5 | AP | 2020-06-30 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-06-30 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 19 |
SUPPL | 5 | Null | 15 |
SUPPL | 7 | Null | 15 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90642
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VALSARTAN","submission":"VALSARTAN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN","submission":"VALSARTAN","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN","submission":"VALSARTAN","actionType":"160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VALSARTAN","submission":"VALSARTAN","actionType":"320MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)