Application Sponsors
| ANDA 080961 | AUROLIFE PHARMA LLC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 4MG | 0 | CHLORPHENIRAMINE MALEATE | CHLORPHENIRAMINE MALEATE |
FDA Submissions
| ORIG | 1 | AP | 1972-12-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 1982-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1983-02-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1983-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 1983-12-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 1984-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 1984-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 1988-11-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 72 | AP | 1989-09-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 1987-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 74 | AP | 1988-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 1988-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 76 | AP | 1988-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 1989-02-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 1995-01-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 1996-03-28 | |
Submissions Property Types
| SUPPL | 60 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 67 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 70 | Null | 0 |
| SUPPL | 72 | Null | 0 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 74 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 76 | Null | 0 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 78 | Null | 0 |
| SUPPL | 79 | Null | 0 |
CDER Filings
AUROLIFE PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 80961
[companyName] => AUROLIFE PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORPHENIRAMINE MALEATE","activeIngredients":"CHLORPHENIRAMINE MALEATE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLORPHENIRAMINE MALEATE","submission":"CHLORPHENIRAMINE MALEATE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)