Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021652
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 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
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
02/17/2021 SUPPL-28 Labeling-Patient Package Insert, Labeling-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-Package Insert, Labeling-Medication Guide 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-Package Insert, Labeling-Medication Guide 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-Medication Guide, Labeling-Package Insert 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-Proposal, Labeling, REMS-Modified 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
02/17/2021 SUPPL-28 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s028lbl.pdf
02/17/2021 SUPPL-28 Labeling-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-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-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-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
03/09/2009 SUPPL-8 REMS-Modified 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

EPZICOM

TABLET;ORAL; EQ 600MG BASE;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 090159 AUROBINDO PHARMA LTD
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 206151 AUROBINDO PHARMA LTD
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 091144 CIPLA
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 204990 LUPIN LTD
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 079246 TEVA PHARMS USA
EPZICOM ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription Yes AB 021652 VIIV HLTHCARE

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