Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201532
Company: EISAI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALAVEN ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
11/15/2010 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/201532s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201532s000_halaven_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201532Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/19/2016 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201532Orig1s016ltr.pdf
01/28/2016 SUPPL-15 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201532Orig1s015ltr.pdf
11/18/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/27/2015 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201532s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201532s013ltr.pdf
04/10/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/19/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201532Orig1s010ltr.pdf
08/01/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201532Orig1s009ltr.pdf
10/24/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/27/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/22/2013 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201532s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201532Orig1s006ltr.pdf
11/07/2012 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/17/2012 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201532s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201532s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/19/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s016lbl.pdf
01/28/2016 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s015lbl.pdf
10/27/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201532s013lbl.pdf
12/19/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s010lbl.pdf
08/01/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201532s009lbl.pdf
08/22/2013 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201532s006lbl.pdf
02/17/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201532s004lbl.pdf
11/15/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf

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