An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 206353
Company: BRISTOL

Summary Review

Products on NDA 206353

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206353

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
05/12/2023	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206353s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206353Orig1s008ltr.pdf
07/31/2020	SUPPL-7	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206353s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206353Orig1s007ltr.pdf
04/22/2020	SUPPL-6	Labeling-Package Insert, Labeling-Patient 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

Labels for NDA 206353

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206353s008lbl.pdf
07/31/2020	SUPPL-7	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206353s007lbl.pdf
04/22/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206353s006lbl.pdf
04/22/2020	SUPPL-6	Labeling-Patient 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

Top