RUBICON FDA Approval ANDA 214415

ANDA 214415

RUBICON

FDA Drug Application

Application #214415

Application Sponsors

ANDA 214415RUBICON

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL5MG0OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
002TABLET, EXTENDED RELEASE;ORAL10MG0OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE
003TABLET, EXTENDED RELEASE;ORAL15MG0OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-27STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214415
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-27
        )

)

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