ANDA 211888

AUROBINDO PHARMA LTD

FDA Drug Application

Application #211888

Application Sponsors

ANDA 211888

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INHALATION	EQ 0.021% BASE	0	ALBUTEROL SULFATE	ALBUTEROL SULFATE
002	SOLUTION;INHALATION	EQ 0.042% BASE	0	ALBUTEROL SULFATE	ALBUTEROL SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AN
002	Prescription	AN

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211888
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.021% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.042% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-20
        )

)