ANDA 206687

FRESENIUS KABI USA

FDA Drug Application

Application #206687

Application Sponsors

ANDA 206687

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

4MEQ/ML

0

SODIUM ACETATE

SODIUM ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-30

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206687
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM ACETATE","activeIngredients":"SODIUM ACETATE","strength":"4MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-30
        )

)