NDA 017575

BAYER HLTHCARE

FDA Drug Application

Application #017575

Application Sponsors

NDA 017575

BAYER HLTHCARE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DTIC-DOME	DACARBAZINE
002	INJECTABLE;INJECTION	200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	DTIC-DOME	DACARBAZINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1975-05-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1979-05-24	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1981-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-07-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	1983-04-05
LABELING; Labeling	SUPPL	9	AP	1986-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1988-12-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1991-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1996-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-09-24	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17575
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)