RUBICON FDA Approval ANDA 216492

ANDA 216492

RUBICON

FDA Drug Application

Application #216492

Application Sponsors

ANDA 216492RUBICON

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL250MG/5ML0GABAPENTINGABAPENTIN

FDA Submissions

UNKNOWN; ORIG1AP2023-01-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216492
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"250MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/18\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-18
        )

)

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