ALKEM LABS LTD FDA Approval ANDA 213375

ANDA 213375

ALKEM LABS LTD

FDA Drug Application

Application #213375

Application Sponsors

ANDA 213375ALKEM LABS LTD

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL500MG/PACKET0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2020-12-02STANDARD
REMS; REMSSUPPL3AP2022-10-12

Submissions Property Types

ORIG1Null7
SUPPL3Null7

TE Codes

001PrescriptionAA

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213375
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-02
        )

)

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