NDA 019398

ICU MEDICAL INC

FDA Drug Application

Application #019398

Documents

• Letter: 2004-05-27

Application Sponsors

NDA 019398

ICU MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

7% (7GM/100ML)

0

AMINOSYN-PF 7%

AMINO ACIDS

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1985-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-12-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	1986-12-15
LABELING; Labeling	SUPPL	6	AP	1987-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2016-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2016-05-24	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19398
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN-PF 7%","activeIngredients":"AMINO ACIDS","strength":"7% (7GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN-PF 7%","submission":"AMINO ACIDS","actionType":"7% (7GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)