ANDA 209476

FRESENIUS KABI USA

FDA Drug Application

Application #209476

Application Sponsors

ANDA 209476

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

3GM/100ML

0

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

SODIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209476
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 3% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"3GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-13
        )

)