ANDA 212070

FRESENIUS KABI USA

FDA Drug Application

Application #212070

Documents

• Letter: 2021-05-06

Application Sponsors

ANDA 212070

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	50MEQ/20ML (2.5MEQ/ML)	0	SODIUM CHLORIDE 14.6%	SODIUM CHLORIDE
002	SOLUTION;INTRAVENOUS	100MEQ/40ML (2.5MEQ/ML)	0	SODIUM CHLORIDE 14.6%	SODIUM CHLORIDE
003	SOLUTION;INTRAVENOUS	400MEQ/100ML (4MEQ/ML)	0	SODIUM CHLORIDE 23.4%	SODIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

002	Prescription	AP
003	Prescription	AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212070
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 14.6%","activeIngredients":"SODIUM CHLORIDE","strength":"50MEQ\/20ML (2.5MEQ\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM CHLORIDE 14.6%","activeIngredients":"SODIUM CHLORIDE","strength":"100MEQ\/40ML (2.5MEQ\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212070Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-28
        )

)