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
BELRAPZO از شرکت EAGLE PHARMS
New Drug Application (NDA): 205580
Company: EAGLE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BELRAPZO | 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 |
|---|---|---|---|---|---|---|---|
| 05/15/2018 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/14/2021 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205580s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205580Orig1s010ltr.pdf |
||
| 10/30/2019 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205580s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205580Orig1s006ltr.pdf |
||
| 08/31/2018 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/14/2021 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205580s010lbl.pdf | |
| 10/30/2019 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205580s006lbl.pdf | |
| 08/31/2018 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf | |
| 08/31/2018 | SUPPL-2 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf | |
| 05/15/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s000lbl.pdf |
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