Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205551
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIUMEQ ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE EQ 600MG BASE;EQ 50MG BASE;300MG TABLET;ORAL Prescription None 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
08/22/2014 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205551s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205551Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205551Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2019 SUPPL-22 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205551Orig1s022ltr.pdf
05/03/2019 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205551Orig1s016ltr.pdf
09/06/2018 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205551Orig1s014s015REPLACEMENTLtr.pdf
09/06/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205551Orig1s014s015REPLACEMENTLtr.pdf
05/11/2018 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205551Orig1s013ltr.pdf
11/21/2017 SUPPL-11 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205551Orig1s011ltr.pdf
03/27/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205551Orig1s010ltr.pdf
04/01/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/21/2016 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205551s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205551Orig1s005ltr.pdf
09/28/2015 SUPPL-4 Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s004ltr.pdf
08/05/2015 SUPPL-2 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s002ltr.pdf
06/15/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/24/2019 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s022lbl.pdf
10/24/2019 SUPPL-22 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s022lbl.pdf
05/03/2019 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s016lbl.pdf
05/03/2019 SUPPL-16 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205551s016lbl.pdf
09/06/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf
09/06/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s014s015lbl.pdf
05/11/2018 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s013lbl.pdf
05/11/2018 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205551s013lbl.pdf
11/21/2017 SUPPL-11 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s011lbl.pdf
03/27/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s010lbl.pdf
04/21/2016 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205551s005lbl.pdf
09/28/2015 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf
09/28/2015 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf
09/28/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf
08/05/2015 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s002lbl.pdf
08/05/2015 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s002lbl.pdf
08/22/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205551s000lbl.pdf

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