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
BICALUTAMIDE از شرکت ACCORD HLTHCARE
Abbreviated New Drug Application (ANDA): 078917
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/06/2009 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078917s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/30/2018 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/30/2018 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/20/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/02/2011 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/15/2009 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/06/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078917s000lbl.pdf |
BICALUTAMIDE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 078917 | ACCORD HLTHCARE |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 200274 | APOTEX INC |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 091011 | KENTON |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 078575 | SANDOZ |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 079110 | SUN PHARM |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 078634 | WATSON LABS TEVA |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 079089 | ZYDUS PHARMS USA INC |
| CASODEX | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 020498 | ANI PHARMS |
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