NDA 007883

TEVA WOMENS

FDA Drug Application

Application #007883

Application Sponsors

NDA 007883

TEVA WOMENS

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	TABLET;ORAL	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	ANTABUSE	DISULFIRAM
003	TABLET;ORAL	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	ANTABUSE	DISULFIRAM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1951-08-28	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1977-01-05
LABELING; Labeling	SUPPL	9	AP	1978-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1980-02-21	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1978-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1979-05-25	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1980-03-20
LABELING; Labeling	SUPPL	14	AP	1980-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-07-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1982-02-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1982-07-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1985-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1984-10-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1985-05-20	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1986-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1987-08-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1989-03-27	PRIORITY
LABELING; Labeling	SUPPL	29	AP	1995-02-21
LABELING; Labeling	SUPPL	30	AP	2000-08-29	STANDARD

Submissions Property Types

SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 7883
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)