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
BENDAMUSTINE HYDROCHLORIDE از شرکت ACCORD HLTHCARE
Abbreviated New Drug Application (ANDA): 205574
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription |
AP |
No | No |
| BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription |
AP |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/21/2020 | ORIG-1 | Tentative Approval |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/21/2020 | ORIG-1 | Tentative Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf |
BENDAMUSTINE HYDROCHLORIDE
POWDER;IV (INFUSION); 25MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 205574 | ACCORD HLTHCARE |
POWDER;IV (INFUSION); 100MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 205574 | ACCORD HLTHCARE |
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