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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206352
Company: BRISTOL MYERS SQUIBB

Summary Review

Products on NDA 206352

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REYATAZ	ATAZANAVIR SULFATE	EQ 50MG BASE/PACKET	POWDER;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206352

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/02/2014	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206352Orig1s000,21567Orig1s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2023	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021567s048,206352s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021567Orig1s048; 206352Orig1s010ltr.pdf
09/24/2020	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021567s044,206352s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021567Orig1s044; 206352Orig1s008ltr.pdf
04/18/2018	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021567s042,206352s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021567Orig1s042,206352Orig1s007ltr.pdf
10/20/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s041,206352s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021567Orig1s041,206352Orig1s006ltr.pdf
05/23/2017	SUPPL-5	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s040,206352s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021567Orig1s040,206352Orig1s005ltr.pdf
09/15/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021567s039,206352s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021567Orig1s039,206352Orig1s004ltr.pdf
09/24/2015	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206352Orig1s003,021567Orig1s038ltr.pdf
03/27/2015	SUPPL-2	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s037,206352Orig1s002ltr.pdf

Labels for NDA 206352

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021567s048,206352s010lbl.pdf
11/07/2023	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021567s048,206352s010lbl.pdf
09/24/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021567s044,206352s008lbl.pdf
09/24/2020	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021567s044,206352s008lbl.pdf
04/18/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021567s042,206352s007lbl.pdf
10/20/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s041,206352s006lbl.pdf
05/23/2017	SUPPL-5	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s040,206352s005lbl.pdf
09/15/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021567s039,206352s004lbl.pdf
09/24/2015	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.pdf
03/27/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf
03/27/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf
06/02/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.pdf

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