ANDA 211221

FRESENIUS KABI USA

FDA Drug Application

Application #211221

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 211221

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

UNKNOWN

UNKNOWN

0

DEXTROSE

DEXTROSE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211221
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.225%","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;225MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-15
        )

)