ANDA 214982

AUROBINDO PHARMA LTD

FDA Drug Application

Application #214982

Documents

• Letter: 2022-08-04

Application Sponsors

ANDA 214982

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	0.0625MG	0	DIGOXIN	DIGOXIN
002	TABLET;ORAL	0.125MG	0	DIGOXIN	DIGOXIN
003	TABLET;ORAL	0.25MG	0	DIGOXIN	DIGOXIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214982
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.0625MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-08
        )

)