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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205677
Company: VANDA PHARMS INC

Summary Review

Products on NDA 205677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HETLIOZ	TASIMELTEON	20MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205677Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2020	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205677Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205677Orig1s007ltr.pdf
10/07/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205677s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205677orig1s006ltr.pdf
04/11/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/12/2014	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205677Orig1s001ltr.pdf

Labels for NDA 205677

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2020	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205677Orig1s007lbl.pdf
10/07/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205677s006lbl.pdf
12/12/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s001lbl.pdf
01/31/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s000lbl.pdf

Therapeutic Equivalents for NDA 205677

HETLIOZ

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HETLIOZ	TASIMELTEON	20MG	CAPSULE;ORAL	Prescription	Yes	AB	205677	VANDA PHARMS INC
TASIMELTEON	TASIMELTEON	20MG	CAPSULE;ORAL	Prescription	No	AB	211607	APOTEX
TASIMELTEON	TASIMELTEON	20MG	CAPSULE;ORAL	Prescription	No	AB	211654	MSN
TASIMELTEON	TASIMELTEON	20MG	CAPSULE;ORAL	Prescription	No	AB	211601	TEVA PHARMS USA INC

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