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
BEXTRA از شرکت GD SEARLE
New Drug Application (NDA): 021341
Company: GD SEARLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BEXTRA | VALDECOXIB | 10MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BEXTRA | VALDECOXIB | 20MG | TABLET;ORAL | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 11/16/2001 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21341lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/24/2004 | SUPPL-6 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21341ltr.pdf |
||
| 04/23/2004 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341se8-003_bextra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21341se8-003ltr.pdf |
||
| 11/01/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21341slr002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021341_S002_BEXTRATOC.cfml |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/24/2004 | SUPPL-6 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341lbl.pdf | |
| 04/23/2004 | SUPPL-3 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341se8-003_bextra_lbl.pdf | |
| 11/16/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21341lbl.pdf |
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