ALKEM LABS LTD FDA Approval ANDA 216067

ANDA 216067

ALKEM LABS LTD

FDA Drug Application

Application #216067

Application Sponsors

ANDA 216067ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL30MG0NIFEDIPINENIFEDIPINE
002TABLET, EXTENDED RELEASE;ORAL60MG0NIFEDIPINENIFEDIPINE
003TABLET, EXTENDED RELEASE;ORAL90MG0NIFEDIPINENIFEDIPINE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB2
002PrescriptionAB2
003PrescriptionAB2

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216067
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIFEDIPINE","activeIngredients":"NIFEDIPINE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIFEDIPINE","activeIngredients":"NIFEDIPINE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIFEDIPINE","activeIngredients":"NIFEDIPINE","strength":"90MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-29
        )

)

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