ANDA 213657

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213657

Application Sponsors

ANDA 213657

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 2MG BASE	0	ALBUTEROL SULFATE	ALBUTEROL SULFATE
002	TABLET;ORAL	EQ 4MG BASE	0	ALBUTEROL SULFATE	ALBUTEROL SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-05-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213657
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-14
        )

)