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ZIDOVUDINE | EQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| 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-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-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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021205s036lbl.pdf | |
| 03/15/2017 | SUPPL-36 | Labeling-Medication Guide | 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021205s034lbl.pdf | |
| 09/30/2015 | SUPPL-34 | Labeling-Medication Guide | 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-Proposal | 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 | |
| 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 |