ANDA 216531

AUROBINDO PHARMA LTD

FDA Drug Application

Application #216531

Application Sponsors

ANDA 216531

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	AMBRISENTAN	AMBRISENTAN
002	TABLET;ORAL	10MG	0	AMBRISENTAN	AMBRISENTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-21

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] => 216531
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-21
        )

)