NDA 020636

BOEHRINGER INGELHEIM

FDA Drug Application

Application #020636

Documents

• Letter: 2003-12-23
• Letter: 2004-05-26
• Letter: 2005-03-02
• Letter: 2008-06-30
• Letter: 2010-07-23
• Letter: 2011-03-31
• Letter: 2011-11-14
• Label: 2004-05-27
• Label: 2007-04-20
• Label: 2010-01-20
• Label: 2011-03-28
• Label: 2014-01-28
• Review: 2007-08-06
• Review: 2007-08-06
• Review: 2004-02-04
• Review: 2007-08-06
• Review: 2005-04-27
• Review: 2007-08-06
• Letter: 2004-06-30
• Letter: 2004-06-30
• Letter: 2002-03-27
• Letter: 2003-08-06
• Letter: 2007-04-20
• Letter: 2007-08-17
• Letter: 2010-01-26
• Letter: 2011-01-14
• Letter: 2011-05-10
• Letter: 2012-11-13
• Letter: 2014-01-28
• Label: 2004-06-30
• Label: 2003-04-04
• Label: 2003-08-06
• Label: 2003-12-29
• Label: 2005-03-02
• Label: 2008-06-26
• Label: 2007-08-17
• Label: 2010-07-22
• Label: 2011-01-10
• Label: 2011-11-10
• Label: 2012-11-15
• Review: 2007-08-06
• Label: 2017-03-28
• Letter: 2017-03-29
• Label: 2018-09-25
• Medication Guide: 2018-09-25
• Letter: 2018-10-01
• Review: 2019-02-15
• Letter: 2022-06-13
• Label: 2022-06-15
• Medication Guide: 2022-06-15

Application Sponsors

NDA 020636

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

1

VIRAMUNE

NEVIRAPINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-06-21	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	1998-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-01-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-09-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-09-19	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1998-05-20	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	1998-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-06-01	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1999-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-08-05	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2000-08-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2000-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-02-23	PRIORITY
LABELING; Labeling	SUPPL	16	AP	2002-12-31	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2002-03-27	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-12-18	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2003-07-29	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-12-22	STANDARD
LABELING; Labeling	SUPPL	22	AP	2004-05-24	STANDARD
LABELING; Labeling	SUPPL	25	AP	2005-02-24	STANDARD
LABELING; Labeling	SUPPL	26	AP	2007-04-13	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	2008-06-24	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2007-08-16	STANDARD
LABELING; Labeling	SUPPL	32	AP	2010-01-13	STANDARD
LABELING; Labeling	SUPPL	35	AP	2010-07-20	STANDARD
REMS; REMS	SUPPL	36	AP	2011-01-07	N/A
LABELING; Labeling	SUPPL	37	AP	2011-03-25	STANDARD
REMS; REMS	SUPPL	38	AP	2011-05-06	N/A
LABELING; Labeling	SUPPL	39	AP	2011-11-09	STANDARD
LABELING; Labeling	SUPPL	42	AP	2012-11-09	STANDARD
LABELING; Labeling	SUPPL	44	AP	2014-01-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2016-04-14	PRIORITY
LABELING; Labeling	SUPPL	48	AP	2017-03-27	STANDARD
LABELING; Labeling	SUPPL	50	AP	2018-09-24	STANDARD
LABELING; Labeling	SUPPL	52	AP	2022-06-10	STANDARD

Submissions Property Types

ORIG	1	Null	41
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	41
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	9
SUPPL	22	Null	9
SUPPL	27	Null	7
SUPPL	32	Null	6
SUPPL	35	Null	7
SUPPL	36	Null	7
SUPPL	37	Null	31
SUPPL	38	Null	6
SUPPL	39	Null	6
SUPPL	42	Null	7
SUPPL	44	Null	7
SUPPL	47	Null	0
SUPPL	48	Null	15
SUPPL	50	Null	7
SUPPL	52	Null	7

TE Codes

001

Prescription

AB

CDER Filings

BOEHRINGER INGELHEIM

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            [supplements] => 
            [actionDate] => 2018-09-24
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)