ANDA 078446

ICU MEDICAL INC

FDA Drug Application

Application #078446

Application Sponsors

ANDA 078446

ICU MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

149MG/100ML;450MG/100ML

0

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

ORIG

1

AP

2008-09-10

TE Codes

001

Prescription

AP

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78446
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"149MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"149MG\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)