RUBICON FDA Approval ANDA 215184

ANDA 215184

RUBICON

FDA Drug Application

Application #215184

Application Sponsors

ANDA 215184RUBICON

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2.5MG0METOLAZONEMETOLAZONE
002TABLET;ORAL5MG0METOLAZONEMETOLAZONE
003TABLET;ORAL10MG0METOLAZONEMETOLAZONE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215184
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOLAZONE","activeIngredients":"METOLAZONE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOLAZONE","activeIngredients":"METOLAZONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOLAZONE","activeIngredients":"METOLAZONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-20
        )

)

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