ALKEM LABS LTD FDA Approval ANDA 214699

ANDA 214699

ALKEM LABS LTD

FDA Drug Application

Application #214699

Application Sponsors

ANDA 214699ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL400MG0IBUPROFENIBUPROFEN
002TABLET;ORAL600MG0IBUPROFENIBUPROFEN
003TABLET;ORAL800MG0IBUPROFENIBUPROFEN

FDA Submissions

UNKNOWN; ORIG1AP2021-09-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214699
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-13
        )

)

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