RUBICON FDA Approval ANDA 213798

ANDA 213798

RUBICON

FDA Drug Application

Application #213798

Application Sponsors

ANDA 213798RUBICON

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 2MG BASE0TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
002CAPSULE;ORALEQ 4MG BASE0TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
003CAPSULE;ORALEQ 6MG BASE0TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-05-27STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213798
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-27
        )

)

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