NDA 019217

ICU MEDICAL INC

FDA Drug Application

Application #019217

Documents

• Letter: 2003-12-11

Application Sponsors

NDA 019217

ICU MEDICAL INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

9MG/ML

1

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1984-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-03-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2003-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-11-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-01-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-04-01	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19217
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"9MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"SODIUM CHLORIDE","actionType":"9MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)