Application Sponsors
Marketing Status
Application Products
001 | CAPSULE;ORAL | 150MG;180MG;15MG | 0 | ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE | ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE |
FDA Submissions
| ORIG | 1 | AP | 1990-10-26 | |
LABELING; Labeling | SUPPL | 2 | AP | 1991-12-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1991-12-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-07-31 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
CDER Filings
MIKART
cder:Array
(
[0] => Array
(
[ApplNo] => 81095
[companyName] => MIKART
[docInserts] => ["",""]
[products] => [{"drugName":"ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE","strength":"150MG;180MG;15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE","actionType":"150MG;180MG;15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)