Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021652
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPZICOM | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 12/10/2021 | SUPPL-29 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s029lbl.pdf | |
| 02/17/2021 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s028lbl.pdf | |
| 02/17/2021 | SUPPL-28 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s028lbl.pdf | |
| 05/10/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021652s024lbl.pdf | |
| 05/10/2019 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021652s024lbl.pdf | |
| 04/27/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf | |
| 04/27/2018 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf | |
| 03/20/2017 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021652s022lbl.pdf | |
| 03/20/2017 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021652s022lbl.pdf | |
| 09/29/2015 | SUPPL-21 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s021lbl.pdf | |
| 09/29/2015 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s021lbl.pdf | |
| 02/19/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s018lbl.pdf | |
| 05/18/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021652s016lbl.pdf | |
| 03/12/2012 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021652s015lbl.pdf | |
| 11/18/2011 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021652s014lbl.pdf | |
| 02/02/2011 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021652s010lbl.pdf | |
| 03/09/2009 | SUPPL-8 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021652s008lbl.pdf | |
| 03/09/2009 | SUPPL-8 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021652s008lbl.pdf | |
| 03/09/2009 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021652s008lbl.pdf | |
| 05/07/2007 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021652s005lbl.pdf | |
| 08/11/2006 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021652s003lbl.pdf | |
| 08/02/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21652lbl.pdf |