NDA 019917

ICU MEDICAL INC

FDA Drug Application

Application #019917

Documents

• Letter: 2016-12-20
• Letter: 2016-12-20
• Label: 2016-12-21
• Label: 2016-12-21
• Label: 2019-10-07
• Letter: 2019-10-09

Application Sponsors

NDA 019917

ICU MEDICAL INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.5MG/ML

0

MORPHINE SULFATE

MORPHINE SULFATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1992-10-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-10-07	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19917
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"0.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019916s019,019917s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019916s016s017,019917s010s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019916s016s017,019917s010s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019916s016s017,019917s010s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019916s016s017,019917s010s011lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"0.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2019-10-07
        )

)