ALKEM LABS LTD FDA Approval ANDA 210316

ANDA 210316

ALKEM LABS LTD

FDA Drug Application

Application #210316

Application Sponsors

ANDA 210316ALKEM LABS LTD

Marketing Status

Prescription001

Application Products

001FOR SUSPENSION;ORAL3.75GM/PACKET0COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-05-06STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210316
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESEVELAM HYDROCHLORIDE","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"3.75GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/16\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-16
        )

)

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