ANDA 076894

COREPHARMA

FDA Drug Application

Application #076894

Documents

• Review: 2008-07-18
• Review: 2008-07-18
• Review: 2008-07-31
• Review: 2008-07-30
• Review: 2008-07-30

Application Sponsors

ANDA 076894

COREPHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	5MG	0	TORSEMIDE	TORSEMIDE
002	TABLET;ORAL	10MG	0	TORSEMIDE	TORSEMIDE
003	TABLET;ORAL	20MG	0	TORSEMIDE	TORSEMIDE
004	TABLET;ORAL	100MG	0	TORSEMIDE	TORSEMIDE

FDA Submissions

	ORIG	1	AP	2005-05-31
S; Supplement	SUPPL	2	AP	2007-11-07
S; Supplement	SUPPL	3	AP	2008-05-09
S; Supplement	SUPPL	4	AP	2008-04-10
LABELING; Labeling	SUPPL	7	AP	2010-09-28
LABELING; Labeling	SUPPL	8	AP	2013-05-06	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

COREPHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76894
            [companyName] => COREPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)