ZYDUS PHARMS FDA Approval ANDA 209465

ANDA 209465

ZYDUS PHARMS

FDA Drug Application

Application #209465

Application Sponsors

ANDA 209465ZYDUS PHARMS

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS200MG/20ML (10MG/ML)0LACOSAMIDELACOSAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209465
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"200MG\/20ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-29
        )

)

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