APOTEX INC FDA Approval ANDA 078868

ANDA 078868

APOTEX INC

FDA Drug Application

Application #078868

Documents

Letter2012-02-10

Application Sponsors

ANDA 078868APOTEX INC

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

ORIG1AP2012-02-03
LABELING; LabelingSUPPL4AP2022-05-25STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78868
            [companyName] => APOTEX INC
            [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":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TIZANIDINE HYDROCHLORIDE","submission":"TIZANIDINE HYDROCHLORIDE","actionType":"EQ 6MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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