NDA 018932

TEVA WOMENS

FDA Drug Application

Application #018932

Documents

• Letter: 2013-10-04
• Label: 2013-10-08

Application Sponsors

NDA 018932

TEVA WOMENS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

REVIA

NALTREXONE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1984-11-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-02-08	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1986-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-04-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-02-02	PRIORITY
EFFICACY; Efficacy	SUPPL	10	AP	1994-12-30	STANDARD
LABELING; Labeling	SUPPL	11	AP	1994-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-06-23	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1999-03-05	STANDARD
LABELING; Labeling	SUPPL	14	AP	1999-03-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	2001-05-15	STANDARD
LABELING; Labeling	SUPPL	17	AP	2013-10-03	901 REQUIRED

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	5	Null	14
SUPPL	7	Null	14
SUPPL	12	Null	14
SUPPL	17	Null	6

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18932
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)