Application Sponsors
ANDA 211518 | ASCENT PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | 100MG | 0 | BENZONATATE | BENZONATATE |
002 | CAPSULE;ORAL | 150MG | 0 | BENZONATATE | BENZONATATE |
003 | CAPSULE;ORAL | 200MG | 0 | BENZONATATE | BENZONATATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-02-22 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
003 | Prescription | AA |
CDER Filings
ASCENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 211518
[companyName] => ASCENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-02-22
)
)