Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021205
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIZIVIR ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE EQ 300MG BASE;150MG;300MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/14/2000 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205.pdf_Trizinir_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205.pdf_Trizinir_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205_Trizinir.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/10/2019 SUPPL-38 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021205s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021205Orig1s038ltr.pdf
04/27/2018 SUPPL-37 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021205s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021205Orig1s037ltr.pdf
03/15/2017 SUPPL-36 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021205s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021205Orig1s036ltr.pdf
02/24/2017 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021205s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021205Orig1s035ltr.pdf
09/30/2015 SUPPL-34 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021205s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021205Orig1s034ltr.pdf
05/18/2012 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021205s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021205s031ltr.pdf
03/12/2012 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021205s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021205s030ltr.pdf
11/18/2011 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021205s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021205s029ltr.pdf
05/13/2011 SUPPL-28 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf
08/04/2010 SUPPL-24 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf
03/31/2011 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021205s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021205s023ltr.pdf
03/09/2009 SUPPL-21 Labeling, REMS-Modified, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021205s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021205s021ltr.pdf
05/07/2007 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021205s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021205s018ltr.pdf
08/11/2006 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021205s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021205s014LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021205_S014_TRIZIVIR_AP.pdf
05/10/2006 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021205_S012_TRIZIVIR_AP.pdf
05/13/2005 SUPPL-11 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021205s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021205s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021205_S011_TRIZIVIR_AP.pdf
11/26/2003 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021205_S010_TRIZIVIR_AP.pdf
10/31/2003 SUPPL-9 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021205_S009_TRIZIVIR_AP.pdf
10/08/2002 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205slr007ltr.pdf
08/13/2002 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205slr006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-205s006_Trizivir.cfm
07/24/2002 SUPPL-5 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021205_S005_TRIZIVIR_AP.pdf
06/04/2002 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205s3,s4ltr.pdf
06/04/2002 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205s3,s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-205s003_Trizivir.cfm
02/05/2002 SUPPL-2 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-205s002_Trizivir.cfm
07/13/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/10/2019 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021205s038lbl.pdf
05/10/2019 SUPPL-38 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021205s038lbl.pdf
04/27/2018 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021205s037lbl.pdf
04/27/2018 SUPPL-37 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021205s037lbl.pdf
03/15/2017 SUPPL-36 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021205s036lbl.pdf
03/15/2017 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021205s036lbl.pdf
02/24/2017 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021205s035lbl.pdf
09/30/2015 SUPPL-34 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021205s034lbl.pdf
09/30/2015 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021205s034lbl.pdf
05/18/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021205s031lbl.pdf
03/12/2012 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021205s030lbl.pdf
11/18/2011 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021205s029lbl.pdf
03/31/2011 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021205s023lbl.pdf
03/09/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021205s021lbl.pdf
03/09/2009 SUPPL-21 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021205s021lbl.pdf
03/09/2009 SUPPL-21 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021205s021lbl.pdf
05/07/2007 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021205s018lbl.pdf
08/11/2006 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021205s014lbl.pdf
05/13/2005 SUPPL-11 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021205s011lbl.pdf
10/08/2002 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s7lbl.pdf
08/13/2002 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s6lbl.pdf
06/04/2002 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s003lbl.pdf
11/14/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205.pdf_Trizinir_Prntlbl.pdf

TRIZIVIR

TABLET;ORAL; EQ 300MG BASE;150MG;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE EQ 300MG BASE;150MG;300MG TABLET;ORAL Prescription No AB 202912 LUPIN LTD
TRIZIVIR ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE EQ 300MG BASE;150MG;300MG TABLET;ORAL Prescription Yes AB 021205 VIIV HLTHCARE

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