HETERO LABS LTD III FDA Approval ANDA 203825

ANDA 203825

HETERO LABS LTD III

FDA Drug Application

Application #203825

Application Sponsors

ANDA 203825HETERO LABS LTD III

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORALEQ 2.5MG BASE0NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDE
002TABLET;ORALEQ 5MG BASE0NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDE
003TABLET;ORALEQ 10MG BASE0NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDE
004TABLET;ORALEQ 20MG BASE0NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-03

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203825
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-03
        )

)

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