ALKEM LABS LTD FDA Approval ANDA 209038

ANDA 209038

ALKEM LABS LTD

FDA Drug Application

Application #209038

Application Sponsors

ANDA 209038ALKEM LABS LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORAL625MG0COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-10-05STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209038
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESEVELAM HYDROCHLORIDE","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"625MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-05
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.