VIIV HLTHCARE FDA Approval NDA 021205

Application #021205

Documents

Letter	2002-02-05
Letter	2004-03-01
Letter	2002-08-13
Letter	2006-08-18
Letter	2009-03-11
Letter	2011-04-04
Letter	2012-05-22
Letter	2015-10-02
Label	2009-04-03
Review	2005-03-08
Letter	2004-06-28
Letter	2004-03-01
Letter	2002-10-08
Letter	2005-05-17
Letter	2007-05-09
Letter	2010-08-10
Letter	2011-05-17
Letter	2011-11-22
Letter	2012-03-13
Label	2004-06-28
Label	2002-06-04
Label	2002-08-13
Label	2002-10-08
Label	2005-05-17
Label	2006-08-14
Label	2007-05-09
Label	2011-04-01
Label	2011-11-25
Label	2012-03-12
Label	2012-05-22
Label	2015-10-07
Review	2004-03-28
Review	2005-04-08
Review	2005-03-08
Review	2007-07-09
Review	2007-07-09
Review	2007-07-09
Review	2007-07-09
Review	2007-07-09
Review	2007-07-09
Label	2017-02-28
Letter	2017-03-03
Letter	2017-03-20
Label	2017-04-18
Letter	2018-05-03
Label	2018-07-12
Letter	2019-05-14
Label	2019-05-15
Medication Guide	2019-05-15
Letter	2021-02-18
Label	2021-02-18

Application Sponsors

NDA 021205

VIIV HLTHCARE

Marketing Status

Prescription

001

Application Products

001

TABLET;ORAL

EQ 300MG BASE;150MG;300MG

TRIZIVIR

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-11-14	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2002-02-05	STANDARD
LABELING; Labeling	SUPPL	3	AP	2002-06-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	2002-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-07-24	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2002-08-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	2002-10-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2003-10-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2003-11-26	PRIORITY
EFFICACY; Efficacy	SUPPL	11	AP	2005-05-13	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2006-05-10	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2006-08-11	STANDARD
LABELING; Labeling	SUPPL	18	AP	2007-05-07	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-03-09	STANDARD
LABELING; Labeling	SUPPL	23	AP	2011-03-31	STANDARD
REMS; REMS	SUPPL	24	AP	2010-08-04	N/A
REMS; REMS	SUPPL	28	AP	2011-05-13	N/A
LABELING; Labeling	SUPPL	29	AP	2011-11-18	901 REQUIRED
LABELING; Labeling	SUPPL	30	AP	2012-03-12	STANDARD
LABELING; Labeling	SUPPL	31	AP	2012-05-18	STANDARD
LABELING; Labeling	SUPPL	34	AP	2015-09-30	STANDARD
LABELING; Labeling	SUPPL	35	AP	2017-02-24	STANDARD
LABELING; Labeling	SUPPL	36	AP	2017-03-15	STANDARD
LABELING; Labeling	SUPPL	37	AP	2018-04-27	STANDARD
LABELING; Labeling	SUPPL	38	AP	2019-05-10	STANDARD
LABELING; Labeling	SUPPL	41	AP	2021-02-17	STANDARD

Submissions Property Types

ORIG	1	Null	41
SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	21	Null	7
SUPPL	23	Null	6
SUPPL	24	Null	6
SUPPL	28	Null	6
SUPPL	29	Null	6
SUPPL	30	Null	6
SUPPL	31	Null	7
SUPPL	34	Null	15
SUPPL	35	Null	6
SUPPL	36	Null	7
SUPPL	37	Null	7
SUPPL	38	Null	15
SUPPL	41	Null	7

TE Codes

001

Prescription

CDER Filings

VIIV HLTHCARE

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(
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            [companyName] => VIIV HLTHCARE
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            [supplements] => 
            [actionDate] => 2019-05-10
        )

)

NDA 021205

VIIV HLTHCARE

FDA Drug Application

Application #021205

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

VIIV HLTHCARE