Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020564
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPIVIR | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | AB | Yes | No |
| EPIVIR | LAMIVUDINE | 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 |
|---|---|---|---|---|---|---|---|
| 11/22/2004 | ORIG-20 | Approval | Type 1 - New Molecular Entity |
Label is not available on this site. |
|||
| 11/17/1995 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020564Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/10/2019 | SUPPL-39 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020564Orig1s039, 020596Orig1s038ltr.pdf | |
| 04/27/2018 | SUPPL-38 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020564s038,020596s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020564Orig1s038,020596Orig1s037ltr.pdf | |
| 09/25/2017 | SUPPL-37 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf | |
| 07/20/2016 | SUPPL-36 | Efficacy-Labeling Change With Clinical Data, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020564s036,020596s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020564Orig1s036,020596Orig1s035ltr.pdf | |
| 09/30/2015 | SUPPL-35 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s035,020596Orig1s034ltr.pdf | |
| 02/19/2015 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s034,020596s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s034,020596Orig1s033ltr.pdf | |
| 03/23/2015 | SUPPL-33 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s033,020596s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s033,020596Orig1s032ltr.pdf | |
| 12/18/2012 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/2011 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020564s031,020596s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020564s031,020596s030ltr.pdf | |
| 02/01/2008 | SUPPL-28 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020564s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020564s028ltr.pdf | |
| 10/25/2006 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020564s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020564s026ltr.pdf | |
| 06/13/2006 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s025,020564s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s025, 020564s024LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020564_S024_Epivir.pdf | |
| 09/29/2004 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s022,20564s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s022,20564s021ltr.pdf | |
| 11/22/2004 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s021,20564s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020564_S020_Epivir.pdf | |
| 11/13/2003 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_epivir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20596slr020,20564slr019ltr.pdf | |
| 09/13/2002 | SUPPL-17 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020564_S017_Epivir.pdf |
| 03/01/2002 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s16ltr.pdf |
| 06/24/2002 | SUPPL-15 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s015ltrand20596s016ltr.pdf | |
| 10/08/2002 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564slr014,20596slr015ltr.pdf | |
| 06/19/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/06/2001 | SUPPL-12 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20596S13LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-564s012_20-596s013_Epivir.cfm |
| 01/05/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/08/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/08/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020564_S007_Epivir.pdf |
| 12/15/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/03/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/31/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/1997 | SUPPL-2 | Efficacy-New Indication |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-1 | Labeling |
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-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf | |
| 05/10/2019 | SUPPL-39 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf | |
| 04/27/2018 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020564s038,020596s037lbl.pdf | |
| 04/27/2018 | SUPPL-38 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020564s038,020596s037lbl.pdf | |
| 09/25/2017 | SUPPL-37 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf | |
| 09/25/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf | |
| 07/20/2016 | SUPPL-36 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020564s036,020596s035lbl.pdf | |
| 07/20/2016 | SUPPL-36 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020564s036,020596s035lbl.pdf | |
| 09/30/2015 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf | |
| 09/30/2015 | SUPPL-35 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf | |
| 03/23/2015 | SUPPL-33 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s033,020596s032lbl.pdf | |
| 02/19/2015 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s034,020596s033lbl.pdf | |
| 11/18/2011 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020564s031,020596s030lbl.pdf | |
| 02/01/2008 | SUPPL-28 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020564s028lbl.pdf | |
| 10/25/2006 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020564s026lbl.pdf | |
| 06/13/2006 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s025,020564s024lbl.pdf | |
| 11/22/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf | |
| 09/29/2004 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s022,20564s021lbl.pdf | |
| 11/13/2003 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_epivir_lbl.pdf | |
| 10/08/2002 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf | |
| 06/24/2002 | SUPPL-15 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.pdf |
EPIVIR
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EPIVIR | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 020564 | VIIV HLTHCARE |
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 091606 | APOTEX |
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077464 | AUROBINDO PHARMA |
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 203586 | BRECKENRIDGE |
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077221 | CIPLA |
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 203277 | HETERO LABS LTD V |
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 205217 | LUPIN LTD |
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 090198 | MACLEODS PHARMS LTD |
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 090457 | STRIDES PHARMA |
| LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 206974 | UPSHER SMITH LABS |
TABLET;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EPIVIR | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | Yes | AB | 020564 | VIIV HLTHCARE |
| LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 091606 | APOTEX |
| LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077464 | AUROBINDO PHARMA |
| LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077221 | CIPLA |
| LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 203277 | HETERO LABS LTD V |
| LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 205217 | LUPIN LTD |
| LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 090198 | MACLEODS PHARMS LTD |
| LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 090457 | STRIDES PHARMA |
| LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 206974 | UPSHER SMITH LABS |