ANDA 209338

FRESENIUS KABI USA

FDA Drug Application

Application #209338

Application Sponsors

ANDA 209338

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

0

LACTATED RINGER'S IN PLASTIC CONTAINER

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-10-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209338
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACTATED RINGER'S IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"20MG\/100ML;30MG\/100ML;600MG\/100ML;310MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/22\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-22
        )

)