ANDA 212346

FRESENIUS KABI USA

FDA Drug Application

Application #212346

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 212346

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML	0	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	DEXTROSE; POTASSIUM CHLORIDE
002	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML	0	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	DEXTROSE; POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212346
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;75MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-10
        )

)