ANDA 209448

FRESENIUS KABI USA

FDA Drug Application

Application #209448

Documents

• Letter: 2018-08-16

Application Sponsors

ANDA 209448

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10GM/100ML

0

DEXTROSE 10% IN PLASTIC CONTAINER

DEXTROSE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209448
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 10% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"10GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209448Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-16
        )

)