Documents
Application Sponsors
NDA 019436 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PRIMACOR | MILRINONE LACTATE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1987-12-31 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1991-07-09 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 1992-03-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-03-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-09-06 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 1995-10-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-06-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-08-15 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-03-16 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 1999-07-06 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2000-11-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-02-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-10-18 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-10-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-09-16 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2003-04-18 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2007-05-01 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2007-10-30 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 19436
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"PRIMACOR","activeIngredients":"MILRINONE LACTATE","strength":"EQ 1MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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] => [{"actionDate":"10\/30\/2007","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019436s021s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2007","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019436s021s022lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PRIMACOR","submission":"MILRINONE LACTATE","actionType":"EQ 1MG 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] => 2007-10-30
)
)