ACCORD HLTHCARE FDA Approval ANDA 214425

ANDA 214425

ACCORD HLTHCARE

FDA Drug Application

Application #214425

Application Sponsors

ANDA 214425ACCORD HLTHCARE

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL500MG/PACKET0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2020-11-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214425
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/13\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-13
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.