NDA 018233

ICU MEDICAL INC

FDA Drug Application

Application #018233

Documents

• Letter: 2005-01-26
• Letter: 2007-11-08
• Letter: 2003-01-24

Application Sponsors

NDA 018233

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	1980-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1980-05-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1980-05-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1981-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1981-03-02	STANDARD
LABELING; Labeling	SUPPL	7	AP	1981-03-02
LABELING; Labeling	SUPPL	8	AP	1982-03-12
LABELING; Labeling	SUPPL	9	AP	1981-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1981-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1982-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1983-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1984-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1982-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1984-10-10	STANDARD
LABELING; Labeling	SUPPL	18	AP	1984-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1983-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1984-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1984-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1983-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1984-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1985-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1985-11-29	STANDARD
LABELING; Labeling	SUPPL	26	AP	1985-11-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1985-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1984-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1985-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1985-05-03	STANDARD
LABELING; Labeling	SUPPL	34	AP	1985-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1986-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1985-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1986-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1986-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1987-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1990-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1990-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1991-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1992-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1991-08-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1995-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1996-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1996-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1996-08-06	STANDARD
LABELING; Labeling	SUPPL	57	AP	2000-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1997-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1998-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1999-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	2002-10-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	2003-01-24	STANDARD
LABELING; Labeling	SUPPL	63	AP	2005-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	2007-11-02	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	2013-09-05	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	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	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	80	Null	0

TE Codes

001

Prescription

AP

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18233
            [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
        )

)