ANDA 213523

FRESENIUS KABI USA

FDA Drug Application

Application #213523

Documents

• Letter: 2021-04-13

Application Sponsors

ANDA 213523

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	INJECTABLE;INJECTION	5GM/100ML;74.5MG/100ML;450MG/100ML	0	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
002	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;450MG/100ML	0	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
003	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;450MG/100ML	0	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
004	INJECTABLE;INJECTION	5GM/100ML;298MG/100ML;450MG/100ML	0	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
005	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;450MG/100ML	0	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP
005	Prescription	AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213523
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;74.5MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;149MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;224MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"5GM\/100ML;298MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-09
        )

)