ANDA 208122

FRESENIUS KABI USA

FDA Drug Application

Application #208122

Application Sponsors

ANDA 208122

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

450MG/100ML

0

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

SODIUM CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2020-11-30	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2022-06-10	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	6	Null	15
SUPPL	11	Null	15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208122
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-23
        )

)