CADILA PHARMS LTD FDA Approval ANDA 208717

ANDA 208717

CADILA PHARMS LTD

FDA Drug Application

Application #208717

Application Sponsors

ANDA 208717CADILA PHARMS LTD

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; ORIG1TA2021-09-08STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

CADILA PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208717
            [companyName] => CADILA PHARMS LTD
            [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":"12\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-17
        )

)

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