Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208194
Company: EAGLE PHARMS
Company: EAGLE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENDEKA | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION;IV (INFUSION) | 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 |
---|---|---|---|---|---|---|---|
12/07/2015 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208194s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208194Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208194Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/11/2024 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208194s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208194Orig1s026ltr.pdf | |
10/14/2021 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208194s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208194Orig1s024ltr.pdf | |
11/08/2019 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208194Orig1s020ltr.pdf | |
10/08/2019 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208194Orig1s019ltr.pdf | |
07/30/2018 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208194s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208194Orig1s013ltr.pdf | |
02/09/2017 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208194s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208194Orig1s005ltr.pdf | |
02/06/2017 | SUPPL-4 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208194Orig1s004.pdf | |
09/23/2016 | SUPPL-3 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208194Orig1s003.pdf | |
06/23/2016 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208194Orig1s001,s002ltr.pdf | |
06/23/2016 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208194Orig1s001,s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/11/2024 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208194s026lbl.pdf | |
10/14/2021 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208194s024lbl.pdf | |
11/08/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s020lbl.pdf | |
10/08/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s019lbl.pdf | |
07/30/2018 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208194s013lbl.pdf | |
02/09/2017 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208194s005lbl.pdf | |
06/23/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf | |
06/23/2016 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf | |
12/07/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208194s000lbl.pdf |