NDA 017609

ICU MEDICAL INC

FDA Drug Application

Application #017609

Application Sponsors

NDA 017609

ICU MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML

0

NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1975-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1975-11-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1975-11-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	1975-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1976-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1976-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1977-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1978-06-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	1976-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1977-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1978-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1978-03-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	1977-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1978-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1978-03-30	STANDARD
LABELING; Labeling	SUPPL	18	AP	1978-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1978-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1978-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1978-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1978-08-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1979-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1978-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1979-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1978-10-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1978-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1978-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1978-12-29	STANDARD
S; Supplement	SUPPL	31	AP	1979-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1979-01-05	STANDARD
LABELING; Labeling	SUPPL	33	AP	1979-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1979-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1979-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1979-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1980-01-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1979-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1979-10-10	STANDARD
LABELING; Labeling	SUPPL	40	AP	1980-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1980-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1980-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1981-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1981-03-02	STANDARD
LABELING; Labeling	SUPPL	45	AP	1981-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1980-10-31	STANDARD
LABELING; Labeling	SUPPL	47	AP	1982-07-08
LABELING; Labeling	SUPPL	48	AP	1981-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1981-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1982-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1982-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1982-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1982-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1982-06-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1983-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1984-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1982-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1984-10-10	STANDARD
LABELING; Labeling	SUPPL	59	AP	1984-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1984-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1983-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1983-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1984-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1984-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1983-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	66	AP	1984-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1989-06-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1984-11-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1985-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	1985-11-29	STANDARD
LABELING; Labeling	SUPPL	71	AP	1985-11-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	1985-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	1984-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1984-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	78	AP	1985-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	79	AP	1984-11-16	STANDARD
LABELING; Labeling	SUPPL	80	AP	1984-11-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	1985-05-03	STANDARD
LABELING; Labeling	SUPPL	82	AP	1985-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	84	AP	1985-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	85	AP	1986-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	1985-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	1986-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	89	AP	1986-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	90	AP	1986-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	1987-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	94	AP	1990-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	95	AP	1990-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	97	AP	1991-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	98	AP	1992-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	99	AP	1991-08-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	102	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	103	AP	1996-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	104	AP	1995-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	105	AP	1996-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	106	AP	1996-08-06	STANDARD
LABELING; Labeling	SUPPL	107	AP	2000-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	108	AP	1997-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	109	AP	1998-10-29	STANDARD
LABELING; Labeling	SUPPL	110	AP	2000-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	127	AP	2013-09-05	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	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	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	46	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	77	Null	0
SUPPL	78	Null	0
SUPPL	79	Null	0
SUPPL	81	Null	0
SUPPL	84	Null	0
SUPPL	85	Null	0
SUPPL	87	Null	0
SUPPL	88	Null	0
SUPPL	89	Null	0
SUPPL	90	Null	0
SUPPL	91	Null	0
SUPPL	94	Null	0
SUPPL	95	Null	0
SUPPL	97	Null	0
SUPPL	98	Null	0
SUPPL	99	Null	0
SUPPL	102	Null	0
SUPPL	103	Null	0
SUPPL	104	Null	0
SUPPL	105	Null	0
SUPPL	106	Null	0
SUPPL	108	Null	0
SUPPL	109	Null	0
SUPPL	127	Null	0

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17609
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","strength":"5GM\/100ML;30MG\/100ML;37MG\/100ML;222MG\/100ML;526MG\/100ML;502MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","actionType":"5GM\/100ML;30MG\/100ML;37MG\/100ML;222MG\/100ML;526MG\/100ML;502MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)