ANDA 207310

FRESENIUS KABI USA

FDA Drug Application

Application #207310

Application Sponsors

ANDA 207310

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

900MG/100ML

0

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

SODIUM CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2019-10-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2020-11-19	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2022-08-04	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	19	Null	7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207310
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"SODIUM CHLORIDE","strength":"900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/24\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/09\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-24
        )

)