TEVA WOMENS FDA Approval NDA 021040

Application #021040

Documents

Letter	1999-10-22
Letter	2003-12-23
Letter	2003-12-23
Letter	2003-12-23
Letter	2004-06-10
Label	1999-10-22
Label	2004-02-10
Label	2004-02-10
Review	2005-08-02
Letter	2003-12-23
Letter	2003-12-23
Letter	2004-07-21
Label	2004-02-10
Label	2004-02-10
Label	2004-02-10
Label	2004-07-21
Label	2017-11-03

Application Sponsors

NDA 021040

TEVA WOMENS

Marketing Status

Discontinued

001

Application Products

001

TABLET;ORAL

1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

PREFEST

ESTRADIOL; NORGESTIMATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1999-10-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2003-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-11-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	2003-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-01-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	2003-12-19	STANDARD
LABELING; Labeling	SUPPL	8	AP	2001-10-30	STANDARD
LABELING; Labeling	SUPPL	9	AP	2003-12-19	STANDARD
LABELING; Labeling	SUPPL	10	AP	2003-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-11-13	STANDARD
LABELING; Labeling	SUPPL	12	AP	2004-07-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-11-01	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	15

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21040
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)