Application Sponsors
| ANDA 086366 | ACI HEALTHCARE LTD | |
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 120MG/5ML;12MG/5ML | 0 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE |
FDA Submissions
| ORIG | 1 | AP | 1979-03-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1984-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1987-07-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1987-07-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1988-05-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1988-05-13 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1989-07-13 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1990-10-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1991-02-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1991-02-13 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1990-10-03 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1993-12-16 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1994-09-28 | |
| LABELING; Labeling | SUPPL | 24 | AP | 1995-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1996-09-09 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1996-09-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1996-08-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1996-09-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1996-09-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1999-02-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1999-03-12 | |
Submissions Property Types
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
CDER Filings
ACI HEALTHCARE LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 86366
[companyName] => ACI HEALTHCARE LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"120MG\/5ML;12MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"120MG\/5ML;12MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)