ANDA 212765

PIRAMAL HLTHCARE UK

FDA Drug Application

Application #212765

Application Sponsors

ANDA 212765

PIRAMAL HLTHCARE UK

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	25MG	0	EPLERENONE	EPLERENONE
002	TABLET;ORAL	50MG	0	EPLERENONE	EPLERENONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PIRAMAL HLTHCARE UK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212765
            [companyName] => PIRAMAL HLTHCARE UK
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPLERENONE","activeIngredients":"EPLERENONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EPLERENONE","activeIngredients":"EPLERENONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-10
        )

)