ANDA 212483

FRESENIUS KABI USA

FDA Drug Application

Application #212483

Application Sponsors

ANDA 212483

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2.4GM/100ML

0

FOSCARNET SODIUM

FOSCARNET SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-29

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212483
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSCARNET SODIUM","activeIngredients":"FOSCARNET SODIUM","strength":"2.4GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOSCARNET SODIUM","submission":"FOSCARNET SODIUM","actionType":"2.4GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)