Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 210192
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JULUCA DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE EQ 50MG BASE;EQ 25MG BASE 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
11/21/2017 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210192s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/210192Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210192Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2018 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210192Orig1s002s004Ltr.pdf
09/06/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210192Orig1s002s004Ltr.pdf
01/17/2018 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210192Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/06/2018 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf
09/06/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s002s004lbl.pdf
01/17/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s001lbl.pdf
01/17/2018 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210192s001lbl.pdf
11/21/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210192s000lbl.pdf

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