ALKEM LABS LTD FDA Approval ANDA 216635

ANDA 216635

ALKEM LABS LTD

FDA Drug Application

Application #216635

Application Sponsors

ANDA 216635ALKEM LABS LTD

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL50MG0DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-07-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216635
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC POTASSIUM","activeIngredients":"DICLOFENAC POTASSIUM","strength":"50MG","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/20\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-20
        )

)

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