ANDA 212347

FRESENIUS KABI USA

FDA Drug Application

Application #212347

Documents

• Label: 2020-10-30
• Letter: 2020-11-02

Application Sponsors

ANDA 212347

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	150MG/100ML;450MG/100ML	0	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	POTASSIUM CHLORIDE; SODIUM CHLORIDE
002	INJECTABLE;INJECTION	300MG/100ML;900MG/100ML	0	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	POTASSIUM CHLORIDE; SODIUM CHLORIDE
003	INJECTABLE;INJECTION	150MG/100ML;900MG/100ML	0	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	POTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212347
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"150MG\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"300MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-17
        )

)