ANDA 209192

FRESENIUS KABI USA

FDA Drug Application

Application #209192

Application Sponsors

ANDA 209192

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10MG PHOSPHATE/ML

0

DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-11-18	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209192
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE SODIUM PHOSPHATE","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 10MG PHOSPHATE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-06
        )

)