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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206843
Company: BRISTOL-MYERS SQUIBB

Summary Review

Products on NDA 206843

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAKLINZA	DACLATASVIR DIHYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
DAKLINZA	DACLATASVIR DIHYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
DAKLINZA	DACLATASVIR DIHYDROCHLORIDE	EQ 90MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206843

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206843s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206843Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206843Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206843s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206843Orig1s008ltr.pdf
11/09/2017	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206843Orig1s007ltr.pdf
02/14/2017	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206843Orig1s006ltr.pdf
12/21/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/13/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s004lbl.pdf
02/05/2016	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206843Orig1s001,s003TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/206843Orig1s001, s003SumR.pdf
02/05/2016	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s002ltr.pdf
02/05/2016	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206843Orig1s001,s003TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/206843Orig1s001, s003SumR.pdf

Labels for NDA 206843

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206843s008lbl.pdf
11/09/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s007lbl.pdf
02/14/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s006lbl.pdf
02/14/2017	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s006lbl.pdf
04/13/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s004lbl.pdf
02/05/2016	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf
02/05/2016	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf
02/05/2016	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf
07/24/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206843s000lbl.pdf

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