ZYDUS FDA Approval ANDA 213957

ANDA 213957

ZYDUS

FDA Drug Application

Application #213957

Application Sponsors

ANDA 213957ZYDUS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL12.5MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
002TABLET;ORAL25MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213957
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-23
        )

)

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