MLV FDA Approval ANDA 211789

ANDA 211789

MLV

FDA Drug Application

Application #211789

Application Sponsors

ANDA 211789MLV

Marketing Status

Prescription001

Application Products

001TABLET;ORAL350MG0CARISOPRODOLCARISOPRODOL

FDA Submissions

UNKNOWN; ORIG1AP2021-10-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

MLV
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211789
            [companyName] => MLV
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-20
        )

)

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