ANDA 211194

FRESENIUS KABI USA

FDA Drug Application

Application #211194

Documents

• Letter: 2020-09-18

Application Sponsors

ANDA 211194

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5GM/100ML;300MG/100ML

0

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

DEXTROSE; SODIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211194
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;300MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-26
        )

)