Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 650MG;30MG | 0 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE |
FDA Submissions
| ORIG | 1 | AP | 1986-03-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1991-10-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1991-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1991-02-08 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1991-02-08 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1988-09-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1988-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1988-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1993-11-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1988-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1989-07-11 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1991-05-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1995-02-08 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1995-05-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1995-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1996-05-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1996-05-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1996-05-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1998-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1998-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | 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 | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
CDER Filings
MIKART
cder:Array
(
[0] => Array
(
[ApplNo] => 89231
[companyName] => MIKART
[docInserts] => ["",""]
[products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"650MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"650MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)