An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	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	215435	INNOGENIX
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

Top