NDA 019222

ICU MEDICAL INC

FDA Drug Application

Application #019222

Application Sponsors

NDA 019222

ICU MEDICAL INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

1

DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1984-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-08-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	1997-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-01-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19222
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)