HETERO LABS LTD V FDA Approval ANDA 204389

ANDA 204389

HETERO LABS LTD V

FDA Drug Application

Application #204389

Application Sponsors

ANDA 204389HETERO LABS LTD V

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
002TABLET;ORAL10MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204389
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-26
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.