NDA 020015

ICU MEDICAL INC

FDA Drug Application

Application #020015

Application Sponsors

NDA 020015

ICU MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10% (10GM/100ML)

0

AMINOSYN II 10% IN PLASTIC CONTAINER

AMINO ACIDS

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1991-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-11-01	STANDARD
LABELING; Labeling	SUPPL	12	AP	2003-06-30
LABELING; Labeling	SUPPL	13	AP	2003-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2011-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2014-09-15	STANDARD

Submissions Property Types

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	10	Null	0
SUPPL	28	Null	15
SUPPL	33	Null	0

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20015
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN II 10% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS","strength":"10% (10GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN II 10% IN PLASTIC CONTAINER","submission":"AMINO ACIDS","actionType":"10% (10GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)