ANDA 209689

FRESENIUS KABI USA

FDA Drug Application

Application #209689

Application Sponsors

ANDA 209689

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

LIQUID;N/A

100%

0

STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209689
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"STERILE WATER FOR INJECTION","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100%","dosageForm":"LIQUID;N\/A","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/24\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-24
        )

)