NDA 019603

ICU MEDICAL INC

FDA Drug Application

Application #019603

Documents

• Label: 2019-01-10
• Letter: 2020-04-30
• Label: 2020-04-30

Application Sponsors

NDA 019603

ICU MEDICAL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Prescription: 004

Application Products

001	INJECTABLE;INJECTION	5GM/100ML	0	MANNITOL 5% IN PLASTIC CONTAINER	MANNITOL
002	INJECTABLE;INJECTION	10GM/100ML	0	MANNITOL 10% IN PLASTIC CONTAINER	MANNITOL
003	INJECTABLE;INJECTION	15GM/100ML	0	MANNITOL 15% IN PLASTIC CONTAINER	MANNITOL
004	INJECTABLE;INJECTION	20GM/100ML	0	MANNITOL 20% IN PLASTIC CONTAINER	MANNITOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1987-01-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	1990-01-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-01-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	1994-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-07-10	STANDARD
LABELING; Labeling	SUPPL	38	AP	2019-01-09	STANDARD
EFFICACY; Efficacy	SUPPL	40	AP	2020-04-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	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	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	38	Null	6
SUPPL	40	Null	15

TE Codes

004

Prescription

AP

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19603
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MANNITOL 10% IN PLASTIC CONTAINER","activeIngredients":"MANNITOL","strength":"10GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MANNITOL 15% IN PLASTIC CONTAINER","activeIngredients":"MANNITOL","strength":"15GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MANNITOL 20% IN PLASTIC CONTAINER","activeIngredients":"MANNITOL","strength":"20GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MANNITOL 5% IN PLASTIC CONTAINER","activeIngredients":"MANNITOL","strength":"5GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/29\/2020","submission":"SUPPL-40","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/019603s040lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019603s038lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019603s038lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MANNITOL 10% IN PLASTIC CONTAINER","submission":"MANNITOL","actionType":"10GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MANNITOL 15% IN PLASTIC CONTAINER","submission":"MANNITOL","actionType":"15GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MANNITOL 20% IN PLASTIC CONTAINER","submission":"MANNITOL","actionType":"20GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MANNITOL 5% IN PLASTIC CONTAINER","submission":"MANNITOL","actionType":"5GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-04-29
        )

)