VGYAAN FDA Approval ANDA 214328

ANDA 214328

VGYAAN

FDA Drug Application

Application #214328

Application Sponsors

ANDA 214328VGYAAN

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200MG0CARBAMAZEPINECARBAMAZEPINE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-16STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

VGYAAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214328
            [companyName] => VGYAAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-16
        )

)

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