ANDA 213532

NEXUS PHARMS

FDA Drug Application

Application #213532

Application Sponsors

ANDA 213532

NEXUS PHARMS

Marketing Status

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

Application Products

001	INJECTABLE;INTRAVENOUS	500MG/100ML (5MG/ML)	0	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM
002	INJECTABLE;INTRAVENOUS	1000MG/100ML (10MG/ML)	0	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM
003	INJECTABLE;INTRAVENOUS	1500MG/100ML (15MG/ML)	0	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

NEXUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213532
            [companyName] => NEXUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM IN SODIUM CHLORIDE","activeIngredients":"LEVETIRACETAM","strength":"500MG\/100ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM IN SODIUM CHLORIDE","activeIngredients":"LEVETIRACETAM","strength":"1000MG\/100ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM IN SODIUM CHLORIDE","activeIngredients":"LEVETIRACETAM","strength":"1500MG\/100ML (15MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-06
        )

)