Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 2.5MG | 0 | TERBUTALINE SULFATE | TERBUTALINE SULFATE |
002 | TABLET;ORAL | 5MG | 0 | TERBUTALINE SULFATE | TERBUTALINE SULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-06-22 | UNKNOWN |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
TWI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 211832
[companyName] => TWI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"TERBUTALINE SULFATE","activeIngredients":"TERBUTALINE SULFATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TERBUTALINE SULFATE","activeIngredients":"TERBUTALINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-06-19
)
)