ICU MEDICAL INC FDA Approval NDA 016366

Application #016366

Documents

Label	2017-09-22
Letter	2017-09-22

Application Sponsors

NDA 016366

ICU MEDICAL INC

Marketing Status

Prescription

001

Application Products

001

INJECTABLE;INJECTION

900MG/100ML

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1972-02-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	1975-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1975-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1975-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1975-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1975-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1975-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1976-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1977-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1978-06-08	STANDARD
LABELING; Labeling	SUPPL	13	AP	1977-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1977-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1978-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1978-03-15	STANDARD
LABELING; Labeling	SUPPL	17	AP	1977-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1978-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1978-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1978-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1978-06-02	STANDARD
LABELING; Labeling	SUPPL	24	AP	1978-06-02
LABELING; Labeling	SUPPL	25	AP	1978-02-08
LABELING; Labeling	SUPPL	26	AP	1978-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1978-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1978-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1978-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1978-11-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1979-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1979-03-27	STANDARD
LABELING; Labeling	SUPPL	34	AP	1979-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1978-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1978-10-27	STANDARD
LABELING; Labeling	SUPPL	37	AP	1978-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1978-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1979-03-27	STANDARD
LABELING; Labeling	SUPPL	40	AP	1979-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1978-10-25	STANDARD
LABELING; Labeling	SUPPL	42	AP	1978-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1979-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1979-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1979-01-05	STANDARD
LABELING; Labeling	SUPPL	46	AP	1979-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1979-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1979-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1979-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1980-04-16	STANDARD
LABELING; Labeling	SUPPL	51	AP	1980-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1980-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1979-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1979-10-10	STANDARD
LABELING; Labeling	SUPPL	55	AP	1980-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1980-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1980-05-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1980-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1981-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1980-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1981-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1981-03-02	STANDARD
LABELING; Labeling	SUPPL	64	AP	1981-03-02
LABELING; Labeling	SUPPL	65	AP	1982-08-31
LABELING; Labeling	SUPPL	66	AP	1981-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1981-07-31	STANDARD
LABELING; Labeling	SUPPL	68	AP	1981-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1981-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	1981-10-21	STANDARD
LABELING; Labeling	SUPPL	71	AP	1981-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	1981-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	1982-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	1982-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	1982-02-01	STANDARD
LABELING; Labeling	SUPPL	76	AP	1982-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1982-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	78	AP	1983-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	79	AP	1984-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	1982-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	1984-10-10	STANDARD
LABELING; Labeling	SUPPL	82	AP	1984-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	83	AP	1983-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	84	AP	1983-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	85	AP	1983-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	86	AP	1983-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	1983-01-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	1983-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	89	AP	1984-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	90	AP	1984-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	1984-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	92	AP	1984-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	1984-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	94	AP	1985-01-08	STANDARD
LABELING; Labeling	SUPPL	95	AP	1985-01-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	96	AP	1986-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	97	AP	1986-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	98	AP	1985-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	99	AP	1985-11-29	STANDARD
LABELING; Labeling	SUPPL	100	AP	1985-11-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	101	AP	1985-04-23	STANDARD
LABELING; Labeling	SUPPL	102	AP	1985-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	104	AP	1985-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	105	AP	1984-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	108	AP	1985-01-18	STANDARD
LABELING; Labeling	SUPPL	109	AP	1985-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	110	AP	1985-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	111	AP	1985-05-03	STANDARD
LABELING; Labeling	SUPPL	114	AP	1985-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	119	AP	1985-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	120	AP	1986-01-31	STANDARD
LABELING; Labeling	SUPPL	122	AP	1985-11-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	123	AP	1985-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	124	AP	1985-06-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	127	AP	1986-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	128	AP	1986-01-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	129	AP	1986-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	130	AP	1986-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	131	AP	1987-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	134	AP	1988-06-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	135	AP	1988-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	136	AP	1989-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	137	AP	1990-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	138	AP	1990-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	140	AP	1991-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	141	AP	1992-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	142	AP	1991-08-30	STANDARD
LABELING; Labeling	SUPPL	145	AP	1994-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	146	AP	1995-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	148	AP	1996-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	149	AP	1996-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	150	AP	1996-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	151	AP	1996-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	152	AP	1997-03-28	STANDARD
LABELING; Labeling	SUPPL	153	AP	1999-06-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	154	AP	1997-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	155	AP	1997-08-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	156	AP	1997-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	157	AP	1998-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	159	AP	2000-05-03	STANDARD
LABELING; Labeling	SUPPL	160	AP	2000-05-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	161	AP	2002-11-01	STANDARD
LABELING; Labeling	SUPPL	167	AP	2006-04-10
LABELING; Labeling	SUPPL	174	AP	2007-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	201	AP	2014-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	212	AP	2014-09-08	STANDARD
LABELING; Labeling	SUPPL	214	AP	2017-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	215	AP	2016-04-27	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	67	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	75	Null	0
SUPPL	77	Null	0
SUPPL	78	Null	0
SUPPL	79	Null	0
SUPPL	80	Null	0
SUPPL	81	Null	0
SUPPL	83	Null	0
SUPPL	84	Null	0
SUPPL	85	Null	0
SUPPL	86	Null	0
SUPPL	87	Null	0
SUPPL	88	Null	0
SUPPL	89	Null	0
SUPPL	90	Null	0
SUPPL	91	Null	0
SUPPL	92	Null	0
SUPPL	93	Null	0
SUPPL	94	Null	0
SUPPL	96	Null	0
SUPPL	97	Null	0
SUPPL	98	Null	0
SUPPL	99	Null	0
SUPPL	101	Null	0
SUPPL	104	Null	0
SUPPL	105	Null	0
SUPPL	108	Null	0
SUPPL	110	Null	0
SUPPL	111	Null	0
SUPPL	119	Null	0
SUPPL	120	Null	0
SUPPL	123	Null	0
SUPPL	124	Null	0
SUPPL	127	Null	0
SUPPL	128	Null	0
SUPPL	129	Null	0
SUPPL	130	Null	0
SUPPL	131	Null	0
SUPPL	134	Null	0
SUPPL	135	Null	0
SUPPL	136	Null	0
SUPPL	137	Null	0
SUPPL	138	Null	0
SUPPL	140	Null	0
SUPPL	141	Null	0
SUPPL	142	Null	0
SUPPL	146	Null	0
SUPPL	148	Null	0
SUPPL	149	Null	0
SUPPL	150	Null	0
SUPPL	151	Null	0
SUPPL	152	Null	0
SUPPL	154	Null	0
SUPPL	155	Null	0
SUPPL	156	Null	0
SUPPL	157	Null	0
SUPPL	159	Null	0
SUPPL	161	Null	0
SUPPL	201	Null	0
SUPPL	212	Null	0
SUPPL	214	Null	15
SUPPL	215	Null	0

TE Codes

001

Prescription

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16366
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/21\/2017","submission":"SUPPL-214","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/016366s214lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"SODIUM CHLORIDE","actionType":"900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-09-21
        )

)

NDA 016366

ICU MEDICAL INC

FDA Drug Application

Application #016366

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

ICU MEDICAL INC