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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021476
Company: WAYLIS THERAP

Medication Guide

Other Important Information from FDA

Products on NDA 021476

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUNESTA	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	AB	Yes	No
LUNESTA	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	AB	Yes	No
LUNESTA	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021476

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021476lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021476ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021476_Lunesta.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2019	SUPPL-38	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021476Orig1s038ltr.pdf
02/06/2019	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021476Orig1s037ltr.pdf
11/07/2018	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021476s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021476Orig1s036ltr.pdf
08/27/2015	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
11/03/2014	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
05/15/2014	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021476Orig1s030ltr.pdf
05/29/2014	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
02/03/2014	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021476Orig1s028ltr.pdf
02/16/2015	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
10/10/2012	SUPPL-26	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476Orig1s024,s026ltr.pdf
04/04/2014	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
10/10/2012	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476Orig1s024,s026ltr.pdf
01/26/2012	SUPPL-21	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476s021ltr.pdf
09/30/2009	SUPPL-15	Labeling		Label is not available on this site.
04/06/2009	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021476s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021476s012ltr.pdf
04/23/2009	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
01/29/2008	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021476s008ltr.pdf
01/29/2008	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021476s005ltr.pdf
05/23/2006	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Labels for NDA 021476

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2019	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf
02/06/2019	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476s037lbl.pdf
11/07/2018	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021476s036lbl.pdf
05/15/2014	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf
02/03/2014	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s028lbl.pdf
10/10/2012	SUPPL-26	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
10/10/2012	SUPPL-24	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
10/10/2012	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
04/06/2009	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021476s012lbl.pdf
01/29/2008	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf
01/29/2008	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf
12/15/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021476lbl.pdf

Therapeutic Equivalents for NDA 021476

LUNESTA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	208451	AUROBINDO PHARMA
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091024	DR REDDYS
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091166	GLENMARK PHARMS LTD
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	205504	HETERO LABS LTD V
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	206222	IPCA LABS LTD
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091124	LUPIN LTD
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	202929	MACLEODS PHARMS LTD
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091151	MYLAN PHARMS INC
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091113	ORBION PHARMS
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091103	SUN PHARM
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091169	TEVA
LUNESTA	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	Yes	AB	021476	WAYLIS THERAP

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	208451	AUROBINDO PHARMA
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091024	DR REDDYS
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091166	GLENMARK PHARMS LTD
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	205504	HETERO LABS LTD V
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	206222	IPCA LABS LTD
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091124	LUPIN LTD
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	202929	MACLEODS PHARMS LTD
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091151	MYLAN PHARMS INC
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091113	ORBION PHARMS
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091103	SUN PHARM
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091169	TEVA
LUNESTA	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	Yes	AB	021476	WAYLIS THERAP

TABLET;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	208451	AUROBINDO PHARMA
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091024	DR REDDYS
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091166	GLENMARK PHARMS LTD
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	205504	HETERO LABS LTD V
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	206222	IPCA LABS LTD
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091124	LUPIN LTD
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	202929	MACLEODS PHARMS LTD
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091151	MYLAN PHARMS INC
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091113	ORBION PHARMS
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091103	SUN PHARM
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091169	TEVA
LUNESTA	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	Yes	AB	021476	WAYLIS THERAP

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