ANDA 206485

FRESENIUS KABI USA

FDA Drug Application

Application #206485

Application Sponsors

ANDA 206485

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	INJECTABLE;INJECTION	4GM/100ML (40MG/ML)	0	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE
002	INJECTABLE;INJECTION	4GM/50ML (80MG/ML)	0	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE
003	INJECTABLE;INJECTION	2GM/50ML (40MG/ML)	0	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE
004	INJECTABLE;INJECTION	20GM/500ML (40MG/ML)	0	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE
005	INJECTABLE;INJECTION	40GM/1000ML (40MG/ML)	0	MAGNESIUM SULFATE IN PLASTIC CONTAINER	MAGNESIUM SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-03-15

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP
005	Prescription	AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206485
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"4GM\/100ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"4GM\/50ML (80MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"2GM\/50ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"20GM\/500ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"40GM\/1000ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-15
        )

)