ANDA 078482

COREPHARMA

FDA Drug Application

Application #078482

Documents

• Letter: 2008-08-05

Application Sponsors

ANDA 078482

COREPHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	2008-07-30
LABELING; Labeling	SUPPL	3	AP	2013-07-11	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-09-21	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78482
            [companyName] => CHARTWELL RX
            [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":"EPLERENONE","submission":"EPLERENONE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"EPLERENONE","submission":"EPLERENONE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)