NDA 021676

BAYER HLTHCARE

FDA Drug Application

Application #021676

Documents

• Letter: 2007-02-02
• Letter: 2011-03-16
• Letter: 2010-04-12
• Letter: 2012-04-12
• Label: 2006-03-22
• Label: 2011-03-14
• Label: 2010-04-16
• Label: 2015-06-04
• Letter: 2006-03-23
• Letter: 2015-06-03
• Label: 2012-04-10
• Review: 2007-08-06
• Review: 2016-02-03
• Other Important Information from FDA: 2011-11-16
• Label: 2017-08-09
• Letter: 2017-08-15
• Label: 2021-06-01
• Label: 2022-05-02
• Letter: 2022-05-03

Application Sponsors

NDA 021676

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG;0.02MG

1

YAZ

DROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2006-03-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2007-01-26	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2011-03-11	STANDARD
LABELING; Labeling	SUPPL	9	AP	2010-04-07	UNKNOWN
LABELING; Labeling	SUPPL	12	AP	2012-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2013-01-31	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-06-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2016-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2014-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2015-07-31	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-08-09	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-04-29	STANDARD

Submissions Property Types

SUPPL	8	Null	7
SUPPL	9	Null	6
SUPPL	12	Null	7
SUPPL	13	Null	0
SUPPL	14	Null	15
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	7
SUPPL	21	Null	7

TE Codes

001

Prescription

AB

CDER Filings

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    [0] => Array
        (
            [ApplNo] => 21676
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)