NDA 018429

ICU MEDICAL INC

FDA Drug Application

Application #018429

Documents

• Letter: 2003-06-22
• Letter: 2004-05-27

Application Sponsors

NDA 018429

ICU MEDICAL INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5.2% (5.2GM/100ML)

0

AMINOSYN-RF 5.2%

AMINO ACIDS

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1980-11-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	1983-01-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-01-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	1983-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-07-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-10-26	STANDARD
LABELING; Labeling	SUPPL	10	AP	1985-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1986-01-31	STANDARD
LABELING; Labeling	SUPPL	14	AP	1987-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1994-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-10-25	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-06-18	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18429
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN-RF 5.2%","activeIngredients":"AMINO ACIDS","strength":"5.2% (5.2GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN-RF 5.2%","submission":"AMINO ACIDS","actionType":"5.2% (5.2GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)