ANDA 215371

FRESENIUS KABI USA

FDA Drug Application

Application #215371

Documents

• Letter: 2022-08-01

Application Sponsors

ANDA 215371

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML

0

KABILYTE

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215371
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"KABILYTE","activeIngredients":"MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE","strength":"30MG\/100ML;37MG\/100ML;368MG\/100ML;526MG\/100ML;502MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-08
        )

)