APOTEX FDA Approval ANDA 207993

ANDA 207993

APOTEX

FDA Drug Application

Application #207993

Application Sponsors

ANDA 207993APOTEX

Marketing Status

Prescription001

Application Products

001CAPSULE;ORALEQ 0.5MG BASE0FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207993
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINGOLIMOD HYDROCHLORIDE","activeIngredients":"FINGOLIMOD HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-18
        )

)

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