Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020857
Company: VIIV HLTHCARE
Company: VIIV HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COMBIVIR | LAMIVUDINE; ZIDOVUDINE | 150MG;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 |
|---|---|---|---|---|---|---|---|
| 09/26/1997 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/10/2019 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020857s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020857Orig1s034ltr.pdf | |
| 04/27/2018 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020857s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020857Orig1s033ltr.pdf | |
| 04/10/2017 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020857s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020857Orig1s032ltr.pdf | |
| 02/24/2017 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020857s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020857Orig1s031ltr.pdf | |
| 09/25/2015 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/20857s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020857Orig1s030ltr.pdf | |
| 11/18/2011 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020857s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020857s028ltr.pdf | |
| 10/01/2010 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020857s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020857s026ltr.pdf | |
| 02/02/2009 | SUPPL-23 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020857s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020857s023ltr.pdf | |
| 04/23/2007 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020857s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020857s021ltr.pdf | |
| 10/25/2006 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020857s020ltr.pdf | |
| 06/27/2006 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020857s018ltr.pdf | |
| 09/29/2004 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20857s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20857s015ltr.pdf | |
| 05/17/2004 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20857slr014_combivir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20857slr014ltr.pdf | |
| 10/08/2002 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr012ltr.pdf | |
| 09/13/2002 | SUPPL-11 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S011_Epivir.pdf |
| 08/09/2002 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr009,010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S010_Combivar.pdf | |
| 08/09/2002 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr009,010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S009_Combivar.pdf | |
| 09/29/2000 | SUPPL-8 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-857s008_Combivir.cfm |
| 02/01/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/12/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1998 | 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-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020857s034lbl.pdf | |
| 04/27/2018 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020857s033lbl.pdf | |
| 04/10/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020857s032lbl.pdf | |
| 02/24/2017 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020857s031lbl.pdf | |
| 09/25/2015 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/20857s030lbl.pdf | |
| 11/18/2011 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020857s028lbl.pdf | |
| 10/01/2010 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020857s026lbl.pdf | |
| 02/02/2009 | SUPPL-23 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020857s023lbl.pdf | |
| 04/23/2007 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020857s021lbl.pdf | |
| 10/25/2006 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s020lbl.pdf | |
| 06/27/2006 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s018lbl.pdf | |
| 09/29/2004 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20857s015lbl.pdf | |
| 05/17/2004 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20857slr014_combivir_lbl.pdf | |
| 10/08/2002 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857s12lbl.pdf | |
| 08/09/2002 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf | |
| 08/09/2002 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf |
COMBIVIR
TABLET;ORAL; 150MG;300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COMBIVIR | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | Yes | AB | 020857 | VIIV HLTHCARE |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 206375 | ANDA REPOSITORY |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 077558 | AUROBINDO PHARMA |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 077411 | CIPLA |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 079124 | HETERO LABS LTD III |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 203259 | HETERO LABS LTD V |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 090246 | LUPIN LTD |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 090679 | MACLEODS PHARMS LTD |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 079128 | STRIDES PHARMA |