Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 300MG;60MG | 0 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE |
FDA Submissions
| ORIG | 1 | AP | 1986-02-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-06-04 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1991-09-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1988-02-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1993-07-20 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1995-05-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1997-05-07 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1997-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1998-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-08-13 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
CDER Filings
MIKART
cder:Array
(
[0] => Array
(
[ApplNo] => 89244
[companyName] => MIKART
[docInserts] => ["",""]
[products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)