ANDA 208283

BRECKENRIDGE

FDA Drug Application

Application #208283

Application Sponsors

ANDA 208283

BRECKENRIDGE

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

2018-09-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208283
            [companyName] => BRECKENRIDGE
            [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":"09\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-14
        )

)