NDA 019438

ICU MEDICAL INC

FDA Drug Application

Application #019438

Documents

• Letter: 2004-05-27

Application Sponsors

NDA 019438

ICU MEDICAL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	INJECTABLE;INJECTION	3.5% (3.5GM/100ML)	0	AMINOSYN II 3.5%	AMINO ACIDS
002	INJECTABLE;INJECTION	5% (5GM/100ML)	0	AMINOSYN II 5%	AMINO ACIDS
003	INJECTABLE;INJECTION	7% (7GM/100ML)	0	AMINOSYN II 7%	AMINO ACIDS
004	INJECTABLE;INJECTION	8.5% (8.5GM/100ML)	0	AMINOSYN II 8.5%	AMINO ACIDS
005	INJECTABLE;INJECTION	10% (10GM/100ML)	0	AMINOSYN II 10%	AMINO ACIDS

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1986-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-12-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	1987-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1992-02-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	1988-12-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-01-22	STANDARD
LABELING; Labeling	SUPPL	13	AP	2003-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-10-25	STANDARD

Submissions Property Types

SUPPL	2	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	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19438
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN II 10%","activeIngredients":"AMINO ACIDS","strength":"10% (10GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 3.5%","activeIngredients":"AMINO ACIDS","strength":"3.5% (3.5GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 5%","activeIngredients":"AMINO ACIDS","strength":"5% (5GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 7%","activeIngredients":"AMINO ACIDS","strength":"7% (7GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 8.5%","activeIngredients":"AMINO ACIDS","strength":"8.5% (8.5GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN II 10%","submission":"AMINO ACIDS","actionType":"10% (10GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 3.5%","submission":"AMINO ACIDS","actionType":"3.5% (3.5GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 5%","submission":"AMINO ACIDS","actionType":"5% (5GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 7%","submission":"AMINO ACIDS","actionType":"7% (7GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 8.5%","submission":"AMINO ACIDS","actionType":"8.5% (8.5GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)