ALKEM LABS LTD FDA Approval ANDA 208315

ANDA 208315

ALKEM LABS LTD

FDA Drug Application

Application #208315

Application Sponsors

ANDA 208315ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, DELAYED RELEASE;ORAL180MG0MYCOPHENOLIC ACIDMYCOPHENOLIC ACID
002TABLET, DELAYED RELEASE;ORAL360MG0MYCOPHENOLIC ACIDMYCOPHENOLIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2021-09-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208315
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"180MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"360MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-23
        )

)

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