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 | 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 |
|---|---|---|---|---|---|---|---|
| 08/02/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21652lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21652ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021652s000_EpzicomTOC.cfm |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021652Orig1s029ltr.pdf | |
| 02/17/2021 | SUPPL-28 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021652Orig1s028ltr.pdf | |
| 05/10/2019 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021652s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021652Orig1s024ltr.pdf | |
| 04/27/2018 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021652Orig1s023ltr.pdf | |
| 03/20/2017 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021652s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021652Orig1s022ltr.pdf | |
| 09/29/2015 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s021ltr.pdf | |
| 09/17/2015 | SUPPL-19 | Efficacy-Pediatric |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s019ltr.pdf |
| 02/19/2015 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021652Orig1s018ltr.pdf | |
| 05/18/2012 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021652s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021652s016ltr.pdf | |
| 03/12/2012 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021652s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021652s015ltr.pdf | |
| 11/18/2011 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021652s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021652s014ltr.pdf | |
| 05/13/2011 | SUPPL-13 | 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-11 | 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 |
| 02/02/2011 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021652s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021652s010ltr.pdf | |
| 03/09/2009 | SUPPL-8 | REMS-Modified, Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021652s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021652s008ltr.pdf | |
| 05/07/2007 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021652s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021652s005ltr.pdf | |
| 08/11/2006 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021652s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021652s003LTR.pdf |
| 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021652s024lbl.pdf | |
| 05/10/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021652s024lbl.pdf | |
| 04/27/2018 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf | |
| 04/27/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf | |
| 03/20/2017 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021652s022lbl.pdf | |
| 03/20/2017 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021652s022lbl.pdf | |
| 09/29/2015 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021652s021lbl.pdf | |
| 09/29/2015 | SUPPL-21 | Labeling-Medication Guide | 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 | Labeling | 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 | |
| 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 |