ANDA 211053

AUROBINDO PHARMA LTD

FDA Drug Application

Application #211053

Documents

• Letter: 2021-01-07

Application Sponsors

ANDA 211053

AUROBINDO PHARMA LTD

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	EQ 2.5MG BASE	0	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE
002	TABLET;ORAL	EQ 5MG BASE	0	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE
003	TABLET;ORAL	EQ 10MG BASE	0	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE
004	TABLET;ORAL	EQ 20MG BASE	0	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-12-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

Accessdata Error

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

)