ANDA 088432

ICU MEDICAL INC

FDA Drug Application

Application #088432

Application Sponsors

ANDA 088432

ICU MEDICAL INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

MEPERIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-08-16
LABELING; Labeling	SUPPL	3	AP	1992-03-06
LABELING; Labeling	SUPPL	7	AP	1992-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-07-22
LABELING; Labeling	SUPPL	20	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	21	AP	2016-12-16	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	20	Null	15
SUPPL	21	Null	15

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88432
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"MEPERIDINE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE","submission":"MEPERIDINE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)