ANDA 211428

FRESENIUS KABI USA

FDA Drug Application

Application #211428

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 211428

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML

0

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211428
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"20MG\/100ML;5GM\/100ML;179MG\/100ML;600MG\/100ML;310MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-09
        )

)