Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201532
Company: EISAI INC
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 | AP | 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 |
---|---|---|---|---|---|
09/13/2022 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201532s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201532Orig1s023ltr.pdf | |
09/30/2021 | SUPPL-21 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201532Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201532Orig1s021ltr.pdf | |
02/19/2021 | SUPPL-20 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201532Orig1s020ltr.pdf |
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 |
---|---|---|---|---|---|
09/13/2022 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201532s023lbl.pdf | |
09/30/2021 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201532Orig1s021lbl.pdf | |
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 |
HALAVEN
SOLUTION;INTRAVENOUS; 1MG/2ML (0.5MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERIBULIN MESYLATE | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217250 | BAXTER HLTHCARE CORP |
ERIBULIN MESYLATE | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218047 | GLAND PHARMA LTD |
ERIBULIN MESYLATE | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218281 | JIANGXI QINGFENG |
ERIBULIN MESYLATE | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214850 | LONG GROVE PHARMS |
HALAVEN | ERIBULIN MESYLATE | 1MG/2ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 201532 | EISAI INC |