ZENARA FDA Approval ANDA 215315

ANDA 215315

ZENARA

FDA Drug Application

Application #215315

Application Sponsors

ANDA 215315ZENARA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL150MG0MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDE
002CAPSULE;ORAL200MG0MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDE
003CAPSULE;ORAL250MG0MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZENARA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215315
            [companyName] => ZENARA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEXILETINE HYDROCHLORIDE","activeIngredients":"MEXILETINE HYDROCHLORIDE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEXILETINE HYDROCHLORIDE","activeIngredients":"MEXILETINE HYDROCHLORIDE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEXILETINE HYDROCHLORIDE","activeIngredients":"MEXILETINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-26
        )

)

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