NDA 019345

ICU MEDICAL INC

FDA Drug Application

Application #019345

Documents

• Letter: 2016-02-24
• Label: 2016-02-23
• Letter: 2018-05-16
• Label: 2018-05-17

Application Sponsors

NDA 019345

ICU MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

30GM/100ML

1

DEXTROSE 30% IN PLASTIC CONTAINER

DEXTROSE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1985-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-02-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	1987-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1990-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1992-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1993-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1993-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1996-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1996-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1997-03-28	STANDARD
LABELING; Labeling	SUPPL	24	AP	1997-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1997-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-12-01	STANDARD
LABELING; Labeling	SUPPL	27	AP	1999-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2002-11-01	STANDARD
LABELING; Labeling	SUPPL	30	AP	2003-06-02
LABELING; Labeling	SUPPL	44	AP	2016-02-22	STANDARD
LABELING; Labeling	SUPPL	47	AP	2018-05-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	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	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	44	Null	7
SUPPL	47	Null	15

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19345
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 30% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"30GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/14\/2018","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2016","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEXTROSE 30% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"30GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-05-14
        )

)