Application Sponsors
ANDA 205885 | WATSON LABS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | TABLET;ORAL | 2.5MG | 0 | TADALAFIL | TADALAFIL |
002 | TABLET;ORAL | 5MG | 0 | TADALAFIL | TADALAFIL |
003 | TABLET;ORAL | 10MG | 0 | TADALAFIL | TADALAFIL |
004 | TABLET;ORAL | 20MG | 0 | TADALAFIL | TADALAFIL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-03-29 | STANDARD |
Submissions Property Types
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205885
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-03-29
)
)