CENTAUR PHARMS PVT FDA Approval ANDA 214051

ANDA 214051

CENTAUR PHARMS PVT

FDA Drug Application

Application #214051

Documents

Letter2022-01-12

Application Sponsors

ANDA 214051CENTAUR PHARMS PVT

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 5MG BASE0IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDE
002TABLET;ORALEQ 7.5MG BASE0IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-30STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CENTAUR PHARMS PVT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214051
            [companyName] => CENTAUR PHARMS PVT
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVABRADINE HYDROCHLORIDE","activeIngredients":"IVABRADINE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IVABRADINE HYDROCHLORIDE","activeIngredients":"IVABRADINE HYDROCHLORIDE","strength":"EQ 7.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-30
        )

)

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