NDA 021225

BAYER HLTHCARE

FDA Drug Application

Application #021225

Documents

• Letter: 2008-05-30
• Letter: 2008-06-06
• Letter: 2008-07-24
• Letter: 2009-11-10
• Letter: 2015-10-26
• Letter: 2013-08-08
• Review: 2004-05-06
• Review: 2016-02-03
• Letter: 2004-01-14
• Letter: 2003-08-29
• Label: 2008-07-22
• Label: 2009-10-14
• Label: 2015-10-26
• Label: 2013-08-09
• Label: 2014-05-30
• Review: 2015-03-09
• Label: 2016-12-21
• Letter: 2016-12-23
• Label: 2017-05-30
• Letter: 2017-05-30
• Label: 2017-06-08
• Letter: 2017-06-09
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2020-08-21
• Letter: 2020-08-21
• Letter: 2021-05-27
• Letter: 2021-06-09
• Label: 2021-06-10
• Label: 2021-08-12
• Letter: 2021-08-12
• Letter: 2022-08-15
• Label: 2022-08-15

Application Sponsors

NDA 021225

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INTRAUTERINE DEVICE;INTRAUTERINE

52MG

1

MIRENA

LEVONORGESTREL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-12-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2001-10-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-11-27	STANDARD
LABELING; Labeling	SUPPL	9	AP	2004-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2003-08-27	STANDARD
LABELING; Labeling	SUPPL	17	AP	2008-05-28	STANDARD
LABELING; Labeling	SUPPL	18	AP	2008-06-02	STANDARD
LABELING; Labeling	SUPPL	19	AP	2008-07-21	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	2009-10-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2014-03-07	STANDARD
LABELING; Labeling	SUPPL	31	AP	2015-10-22	STANDARD
LABELING; Labeling	SUPPL	32	AP	2013-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2014-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2014-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2014-12-08	STANDARD
LABELING; Labeling	SUPPL	36	AP	2021-06-08	STANDARD
LABELING; Labeling	SUPPL	37	AP	2016-12-21	STANDARD
EFFICACY; Efficacy	SUPPL	38	AP	2017-06-08	STANDARD
LABELING; Labeling	SUPPL	39	AP	2017-05-25	STANDARD
EFFICACY; Efficacy	SUPPL	40	AP	2020-08-20	STANDARD
LABELING; Labeling	SUPPL	41	AP	2021-05-26	STANDARD
EFFICACY; Efficacy	SUPPL	42	AP	2021-08-11	STANDARD
EFFICACY; Efficacy	SUPPL	43	AP	2022-08-12	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	27	Null	6
SUPPL	29	Null	0
SUPPL	31	Null	15
SUPPL	32	Null	6
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	15
SUPPL	37	Null	7
SUPPL	38	Null	7
SUPPL	39	Null	15
SUPPL	40	Null	6
SUPPL	41	Null	6
SUPPL	42	Null	6
SUPPL	43	Null	6

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 21225
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)