RUBICON FDA Approval ANDA 204882

ANDA 204882

RUBICON

FDA Drug Application

Application #204882

Application Sponsors

ANDA 204882RUBICON

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 25MG BASE0SILDENAFIL CITRATESILDENAFIL CITRATE
002TABLET;ORALEQ 50MG BASE0SILDENAFIL CITRATESILDENAFIL CITRATE
003TABLET;ORALEQ 100MG BASE0SILDENAFIL CITRATESILDENAFIL CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2018-06-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204882
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-11
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.