NDA 018090

ICU MEDICAL INC

FDA Drug Application

Application #018090

Documents

• Label: 2017-09-18
• Label: 2017-09-21
• Letter: 2017-09-22

Application Sponsors

NDA 018090

ICU MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

450MG/100ML

1

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1979-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1979-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-07-06	STANDARD
LABELING; Labeling	SUPPL	4	AP	1980-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1979-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1979-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1979-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1979-10-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	1980-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1980-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1980-05-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1980-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1980-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1980-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1981-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1981-03-02	STANDARD
LABELING; Labeling	SUPPL	17	AP	1981-03-02
LABELING; Labeling	SUPPL	18	AP	1982-08-31
LABELING; Labeling	SUPPL	19	AP	1981-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1981-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1982-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1982-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1982-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1982-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1983-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1984-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1982-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1984-10-10	STANDARD
LABELING; Labeling	SUPPL	29	AP	1984-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1983-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1984-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1984-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1983-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1984-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1989-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1986-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1985-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1985-11-29	STANDARD
LABELING; Labeling	SUPPL	39	AP	1985-11-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1985-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1984-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1985-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1985-05-03	STANDARD
LABELING; Labeling	SUPPL	47	AP	1985-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1986-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1985-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1986-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1986-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1987-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1988-02-16	STANDARD
LABELING; Labeling	SUPPL	58	AP	1988-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1990-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1990-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1993-10-25	STANDARD
LABELING; Labeling	SUPPL	62	AP	1993-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1991-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1992-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	66	AP	1991-08-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1994-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	1995-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	1996-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	1996-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	1996-08-06	STANDARD
LABELING; Labeling	SUPPL	75	AP	1999-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	1997-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1998-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	78	AP	1998-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	2001-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	2002-11-01	STANDARD
LABELING; Labeling	SUPPL	86	AP	2017-04-16	STANDARD
LABELING; Labeling	SUPPL	87	AP	2007-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	105	AP	2014-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	114	AP	2014-09-08	STANDARD
LABELING; Labeling	SUPPL	116	AP	2017-09-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	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	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	49	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	57	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	71	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	76	Null	0
SUPPL	77	Null	0
SUPPL	78	Null	0
SUPPL	80	Null	0
SUPPL	81	Null	0
SUPPL	105	Null	0
SUPPL	114	Null	0
SUPPL	116	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18090
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/21\/2017","submission":"SUPPL-116","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018090sS116lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/1999","submission":"SUPPL-75","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/018090s075lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"SODIUM CHLORIDE","actionType":"450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-09-21
        )

)