Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021205
Company: VIIV HLTHCARE
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 | Discontinued | None | Yes | No |
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 |
|---|---|---|---|---|---|
| 02/17/2021 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021205s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021205Orig1s041ltr.pdf | |
| 05/10/2019 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
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-Medication Guide, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 02/17/2021 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021205s041lbl.pdf | |
| 05/10/2019 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021205s038lbl.pdf | |
| 05/10/2019 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021205s038lbl.pdf | |
| 04/27/2018 | SUPPL-37 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021205s037lbl.pdf | |
| 04/27/2018 | SUPPL-37 | Labeling-Package Insert | 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 |