NDA 019869

ICU MEDICAL INC

FDA Drug Application

Application #019869

Application Sponsors

NDA 019869

ICU MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

LIQUID;N/A

100%

1

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

STERILE WATER FOR INJECTION

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1989-12-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1992-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-08-14	STANDARD
LABELING; Labeling	SUPPL	8	AP	1999-11-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-03-20	STANDARD
LABELING; Labeling	SUPPL	12	AP	2003-05-20

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0

TE Codes

001

Prescription

AP

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19869
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"STERILE WATER FOR INJECTION IN PLASTIC CONTAINER","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100%","dosageForm":"LIQUID;N\/A","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STERILE WATER FOR INJECTION IN PLASTIC CONTAINER","submission":"STERILE WATER FOR INJECTION","actionType":"100%","submissionClassification":"LIQUID;N\/A","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)