AUROBINDO PHARMA LTD FDA Approval ANDA 211053

ANDA 211053

AUROBINDO PHARMA LTD

FDA Drug Application

Application #211053

Documents

Letter2021-01-07

Application Sponsors

ANDA 211053AUROBINDO PHARMA LTD

Marketing Status

None (Tentative Approval)001
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; ORIG1TA2020-12-29STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211053
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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