NDA 018700

SANOFI AVENTIS US

FDA Drug Application

Application #018700

Application Sponsors

NDA 018700

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

INOCOR

INAMRINONE LACTATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1984-07-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	1985-12-02
LABELING; Labeling	SUPPL	3	AP	1985-05-13
LABELING; Labeling	SUPPL	4	AP	1985-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-07-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	1987-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-01-15	STANDARD
LABELING; Labeling	SUPPL	8	AP	2007-12-07
LABELING; Labeling	SUPPL	9	AP	1989-12-15
LABELING; Labeling	SUPPL	10	AP	1987-09-24
LABELING; Labeling	SUPPL	11	AP	1988-01-07
LABELING; Labeling	SUPPL	12	AP	1988-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-08-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	1989-12-15
LABELING; Labeling	SUPPL	15	AP	1990-07-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1990-12-31	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1995-04-19	STANDARD
LABELING; Labeling	SUPPL	19	AP	2000-01-28	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18700
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"INOCOR","activeIngredients":"INAMRINONE LACTATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"INOCOR","submission":"INAMRINONE LACTATE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)