Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020857
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 077558 AUROBINDO PHARMA LTD
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 202418 AUROBINDO PHARMA LTD
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 206375 SHANGHAI DESANO
LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET;ORAL Prescription No AB 079128 STRIDES PHARMA

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