Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022529
Company: EISAI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BELVIQ LORCASERIN HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022529lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022529Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022529Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/23/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022529Orig1s005,022529Orig1s007,208524Orig1s001ltr.pdf
04/06/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/23/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022529Orig1s005,022529Orig1s007,208524Orig1s001ltr.pdf
07/30/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/09/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022529s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022529Orig1s003ltr.pdf
11/01/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/04/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/23/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf
05/23/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf
12/09/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022529s003lbl.pdf
06/27/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022529lbl.pdf

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