ANDA 020345

ICU MEDICAL INC

FDA Drug Application

Application #020345

Application Sponsors

ANDA 020345

ICU MEDICAL INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

8% (8GM/100ML)

0

AMINOSYN-HF 8%

AMINO ACIDS

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1996-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-07-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2005-09-15

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20345
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN-HF 8%","activeIngredients":"AMINO ACIDS","strength":"8% (8GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN-HF 8%","submission":"AMINO ACIDS","actionType":"8% (8GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)