NDA 020977

VIIV HLTHCARE

FDA Drug Application

Application #020977

Documents

• Letter: 1998-12-17
• Letter: 2003-07-28
• Letter: 2004-04-20
• Letter: 2009-08-25
• Letter: 2004-08-05
• Letter: 2012-03-19
• Letter: 2012-05-22
• Letter: 2015-03-25
• Letter: 2015-02-24
• Letter: 2015-10-02
• Label: 2002-10-02
• Label: 2002-08-14
• Label: 2003-09-25
• Label: 2004-08-05
• Label: 2006-08-14
• Label: 2008-07-22
• Label: 2009-01-02
• Label: 2011-11-22
• Review: 2007-09-26
• Letter: 2002-01-28
• Letter: 2002-10-02
• Letter: 2002-08-14
• Letter: 2009-08-25
• Letter: 2004-07-28
• Letter: 2006-08-21
• Letter: 2007-05-09
• Letter: 2008-07-23
• Letter: 2008-12-29
• Letter: 2010-08-10
• Letter: 2011-05-17
• Letter: 2011-11-22
• Letter: 2013-09-13
• Label: 1998-12-17
• Label: 2004-05-03
• Label: 2004-07-28
• Label: 2007-05-09
• Label: 2012-03-16
• Label: 2012-05-22
• Label: 2013-09-17
• Label: 2015-04-01
• Label: 2015-02-20
• Label: 2015-10-07
• Review: 1998-12-17
• Review: 2004-04-14
• Review: 2007-09-26
• Other Important Information from FDA: 2003-12-12
• Label: 2017-03-21
• Letter: 2017-03-24
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Letter: 2018-05-10
• Letter: 2018-05-10
• Label: 2018-05-18
• Label: 2018-05-18
• Medication Guide: 2018-05-18
• Pediatric Statistical Review: 2019-12-05
• Label: 2020-11-25
• Medication Guide: 2020-11-25
• Letter: 2020-11-27

Application Sponsors

NDA 020977

VIIV HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 300MG BASE

1

ZIAGEN

ABACAVIR SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1998-12-17	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2000-12-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2000-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-07-13	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2002-01-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2002-06-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2002-10-02	STANDARD
LABELING; Labeling	SUPPL	8	AP	2002-08-14	STANDARD
LABELING; Labeling	SUPPL	10	AP	2003-07-17	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2004-04-15	UNKNOWN
EFFICACY; Efficacy	SUPPL	12	AP	2004-08-02	UNKNOWN
LABELING; Labeling	SUPPL	13	AP	2004-07-26	STANDARD
LABELING; Labeling	SUPPL	14	AP	2006-08-11	STANDARD
LABELING; Labeling	SUPPL	16	AP	2007-05-07	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2008-07-18	UNKNOWN
LABELING; Labeling	SUPPL	19	AP	2008-12-19	901 ORDER
REMS; REMS	SUPPL	20	AP	2010-08-04	N/A
REMS; REMS	SUPPL	22	AP	2011-05-13	N/A
LABELING; Labeling	SUPPL	23	AP	2011-11-18	901 REQUIRED
LABELING; Labeling	SUPPL	24	AP	2012-03-15	STANDARD
LABELING; Labeling	SUPPL	25	AP	2012-05-18	STANDARD
LABELING; Labeling	SUPPL	26	AP	2013-09-11	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	2015-03-23	STANDARD
LABELING; Labeling	SUPPL	28	AP	2015-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2015-07-21	PRIORITY
LABELING; Labeling	SUPPL	30	AP	2015-09-30	STANDARD
LABELING; Labeling	SUPPL	32	AP	2017-03-20	STANDARD
LABELING; Labeling	SUPPL	33	AP	2018-05-09	STANDARD
LABELING; Labeling	SUPPL	34	AP	2018-05-09	STANDARD
LABELING; Labeling	SUPPL	35	AP	2020-11-24	STANDARD

Submissions Property Types

ORIG	1	Null	41
SUPPL	4	Null	0
SUPPL	11	Null	9
SUPPL	12	Null	31
SUPPL	19	Null	6
SUPPL	20	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	15
SUPPL	24	Null	6
SUPPL	25	Null	6
SUPPL	26	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	15
SUPPL	29	Null	0
SUPPL	30	Null	15
SUPPL	32	Null	15
SUPPL	33	Null	6
SUPPL	34	Null	6
SUPPL	35	Null	7

TE Codes

001

Prescription

AB

CDER Filings

VIIV HLTHCARE

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