Application Sponsors
| ANDA 083951 | GLAXOSMITHKLINE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 300MG;30MG | 0 | EMPRACET W/ CODEINE PHOSPHATE #3 | ACETAMINOPHEN; CODEINE PHOSPHATE |
| 002 | TABLET;ORAL | 300MG;60MG | 0 | EMPRACET W/ CODEINE PHOSPHATE #4 | ACETAMINOPHEN; CODEINE PHOSPHATE |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 83951
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"EMPRACET W\/ CODEINE PHOSPHATE #3","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"EMPRACET W\/ CODEINE PHOSPHATE #4","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"EMPRACET W\/ CODEINE PHOSPHATE #3","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"EMPRACET W\/ CODEINE PHOSPHATE #4","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)