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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021782
Company: TAKEDA PHARMS USA

Medication Guide

Other Important Information from FDA

Products on NDA 021782

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROZEREM	RAMELTEON	8MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021782

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/2005	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021782lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021782ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021782s000_RozeremTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2021	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021782s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021782Orig1s022ltr.pdf
12/21/2018	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021782s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021782Orig1s021Ltr.pdf
07/13/2016	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/14/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/04/2011	SUPPL-15	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021782s015ltr.pdf
03/01/2012	SUPPL-14	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021782s006,s012,s014ltr.pdf
02/21/2012	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021782s006,s012,s014ltr.pdf
11/09/2010	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021782s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021782s011ltr.pdf
10/20/2008	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021782s008, s009, s010ltr.pdf
10/20/2008	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021782s008, s009, s010ltr.pdf
10/20/2008	SUPPL-8	REMS-Proposal, Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021782s008, s009, s010ltr.pdf
03/01/2012	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021782s006,s012,s014ltr.pdf
08/18/2005	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021782s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021782s001ltr.pdf

Labels for NDA 021782

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021782s022lbl.pdf
12/21/2018	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021782s021lbl.pdf
11/09/2010	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021782s011lbl.pdf
10/20/2008	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf
10/20/2008	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf
10/20/2008	SUPPL-8	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf
10/20/2008	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf
08/18/2005	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021782s001lbl.pdf
07/22/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021782lbl.pdf

Therapeutic Equivalents for NDA 021782

ROZEREM

TABLET;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	091610	ACTAVIS LABS FL INC
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	215435	ANDAS 5 HOLDING
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	215972	AUROBINDO PHARMA LTD
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	091693	DR REDDYS LABS SA
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	213186	GRANULES
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	212650	I3 PHARMS
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	215243	MICRO LABS
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	213815	UPSHER SMITH LABS
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	216209	XIROMED
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	211567	ZYDUS PHARMS
ROZEREM	RAMELTEON	8MG	TABLET;ORAL	Prescription	Yes	AB	021782	TAKEDA PHARMS USA

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