Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021782
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROZEREM RAMELTEON 8MG TABLET;ORAL Prescription AB Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 091693 DR REDDYS LABS SA
ROZEREM RAMELTEON 8MG TABLET;ORAL Prescription Yes AB 021782 TAKEDA PHARMS USA

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