NDA 019436

SANOFI AVENTIS US

FDA Drug Application

Application #019436

Documents

• Letter: 2003-04-18
• Letter: 2007-05-07
• Letter: 2007-11-08
• Label: 2019-01-24
• Label: 2019-01-24

Application Sponsors

NDA 019436

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

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EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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LACTATE","strength":"EQ 1MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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
        )

)