Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206353
Company: BRISTOL-MYERS SQUIBB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVOTAZ ATAZANAVIR SULFATE; COBICISTAT EQ 300MG BASE;150MG 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
01/29/2015 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206353Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206353Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206353Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/22/2020 SUPPL-6 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206353s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206353Orig1s006ltr.pdf
04/18/2018 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206353s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206353Orig1s005ltr.pdf
01/27/2017 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206353s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206353Orig1s003ltr.pdf
07/01/2016 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206353s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206353Orig1s002ltr.pdf
07/23/2015 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206353Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/22/2020 SUPPL-6 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206353s006lbl.pdf
04/22/2020 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206353s006lbl.pdf
04/18/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206353s005lbl.pdf
01/27/2017 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206353s003lbl.pdf
07/01/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206353s002lbl.pdf
07/01/2016 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206353s002lbl.pdf
07/23/2015 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s001lbl.pdf
01/29/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s000lbl.pdf

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