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
BEXAROTENE از شرکت ANI PHARMS
Abbreviated New Drug Application (ANDA): 209861
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 05/08/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/23/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
BEXAROTENE
CAPSULE;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 210105 | AMNEAL PHARMS NY |
| BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209861 | ANI PHARMS |
| BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 203174 | BIONPHARMA INC |
| BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 203663 | HIKMA PHARMS |
| BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209931 | TEVA PHARMS USA |
| BEXAROTENE | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | No | AB | 209886 | UPSHER SMITH LABS |
| TARGRETIN | BEXAROTENE | 75MG | CAPSULE;ORAL | Prescription | Yes | AB | 021055 | VALEANT LUXEMBOURG |
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