Application Sponsors
ANDA 040587 | SUN PHARM INDS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | CAPSULE;ORAL | 100MG | 0 | BENZONATATE | BENZONATATE |
002 | CAPSULE;ORAL | 200MG | 0 | BENZONATATE | BENZONATATE |
FDA Submissions
| ORIG | 1 | AP | 2008-03-19 | |
LABELING; Labeling | SUPPL | 5 | AP | 2011-04-26 | |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 40587
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BENZONATATE","submission":"BENZONATATE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BENZONATATE","submission":"BENZONATATE","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)