ALKEM LABS LTD FDA Approval ANDA 206765

ANDA 206765

ALKEM LABS LTD

FDA Drug Application

Application #206765

Application Sponsors

ANDA 206765ALKEM LABS LTD

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL10MG0DALFAMPRIDINEDALFAMPRIDINE

FDA Submissions

UNKNOWN; ORIG1AP2018-07-30STANDARD
LABELING; LabelingSUPPL6AP2021-09-15STANDARD
LABELING; LabelingSUPPL7AP2021-09-15STANDARD

Submissions Property Types

ORIG1Null7
SUPPL6Null7
SUPPL7Null7

TE Codes

001PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206765
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DALFAMPRIDINE","activeIngredients":"DALFAMPRIDINE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-30
        )

)

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