اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BENDEKA از شرکت EAGLE PHARMS
New Drug Application (NDA): 208194
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208194s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/14/2021 | SUPPL-24 | Labeling-Package Insert |
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 |
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 |
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 |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208194Orig1s004.pdf |
||
| 09/23/2016 | SUPPL-3 |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 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 |
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