Documents
Application Sponsors
| NDA 020343 | SANOFI AVENTIS US | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE |
| 002 | INJECTABLE;INJECTION | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE |
| 003 | INJECTABLE;INJECTION | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE |
| 004 | INJECTABLE;INJECTION | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1994-08-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-08-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-06-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-08-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-02-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1999-07-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2000-11-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-10-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2002-09-16 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2003-04-09 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2007-05-01 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2007-10-30 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | 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 | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 20343
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MILRINONE LACTATE","strength":"EQ 10MG BASE\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MILRINONE LACTATE","strength":"EQ 15MG BASE\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MILRINONE LACTATE","strength":"EQ 20MG BASE\/100ML (EQ 0.2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MILRINONE LACTATE","strength":"EQ 40MG BASE\/200ML (EQ 0.2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"MILRINONE LACTATE","actionType":"EQ 10MG BASE\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"MILRINONE LACTATE","actionType":"EQ 15MG BASE\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"MILRINONE LACTATE","actionType":"EQ 20MG BASE\/100ML (EQ 0.2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"MILRINONE LACTATE","actionType":"EQ 40MG BASE\/200ML (EQ 0.2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)