Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204790
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIVICAY DOLUTEGRAVIR SODIUM EQ 50MG BASE TABLET;ORAL Prescription None Yes Yes
TIVICAY DOLUTEGRAVIR SODIUM EQ 10MG BASE TABLET;ORAL Prescription None Yes No
TIVICAY DOLUTEGRAVIR SODIUM EQ 25MG BASE TABLET;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/12/2013 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204790lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204790Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204790Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204790Orig1S000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/27/2017 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204790s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204790Orig1s013ltr.pdf
12/20/2016 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/08/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/09/2016 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204790Orig1s008ltr.pdf
04/22/2016 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204790Orig1s007ltr.pdf
11/05/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/05/2015 SUPPL-5 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204790s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204790Orig1s005ltr.pdf
07/30/2015 SUPPL-4 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

08/29/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/19/2014 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204790Orig1s002ltr.pdf
05/12/2014 SUPPL-1 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204790Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/27/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204790s013lbl.pdf
06/09/2016 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790Orig1s008lbl.pdf
04/22/2016 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204790s007lbl.pdf
08/05/2015 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204790s005lbl.pdf
08/05/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204790s005lbl.pdf
12/19/2014 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s002lbl.pdf
05/12/2014 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf
05/12/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf
08/12/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204790lbl.pdf

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