Application Sponsors
| ANDA 207110 | WATSON LABS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 62.5MG | 0 | BOSENTAN | BOSENTAN |
| 002 | TABLET;ORAL | 125MG | 0 | BOSENTAN | BOSENTAN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-11-04 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2022-04-29 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207110
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"BOSENTAN","activeIngredients":"BOSENTAN","strength":"62.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BOSENTAN","activeIngredients":"BOSENTAN","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-04
)
)