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
BENDECTIN از شرکت SANOFI AVENTIS US
New Drug Application (NDA): 010598
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENDECTIN | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 07/30/1956 | ORIG-1 | Approval |
Type 4 – New Combination |
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 |
|---|---|---|---|---|---|
| 12/09/1982 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/07/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/16/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/22/1981 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/09/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/06/1979 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/25/1979 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1978 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/01/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/09/1976 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/09/1976 | SUPPL-2 | Efficacy |
Label is not available on this site. |
نظرات کاربران