NDA 020137

ROCHE

FDA Drug Application

Application #020137

Documents

• Letter: 2002-06-20
• Review: 1997-10-09

Application Sponsors

NDA 020137

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DEMADEX	TORSEMIDE
002	INJECTABLE;INJECTION	50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DEMADEX	TORSEMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1993-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-08-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-11-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-06-17	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	1997-09-09	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	1998-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-04-20	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20137
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEMADEX","activeIngredients":"TORSEMIDE","strength":"20MG\/2ML (10MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DEMADEX","activeIngredients":"TORSEMIDE","strength":"50MG\/5ML (10MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEMADEX","submission":"TORSEMIDE","actionType":"20MG\/2ML (10MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DEMADEX","submission":"TORSEMIDE","actionType":"50MG\/5ML (10MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)