NDA 019893

ICU MEDICAL INC

FDA Drug Application

Application #019893

Application Sponsors

NDA 019893

ICU MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

70GM/100ML

1

DEXTROSE 70% IN PLASTIC CONTAINER

DEXTROSE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1989-12-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-08-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	1997-08-22
LABELING; Labeling	SUPPL	11	AP	1999-01-05
LABELING; Labeling	SUPPL	12	AP	1999-05-19
LABELING; Labeling	SUPPL	13	AP	1999-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-11-01	STANDARD
LABELING; Labeling	SUPPL	16	AP	2003-12-18

Submissions Property Types

SUPPL	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	14	Null	0

TE Codes

001

Prescription

AP

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19893
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 70% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"70GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROSE 70% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"70GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)