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
BENEMID از شرکت MERCK
New Drug Application (NDA): 007898
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENEMID | PROBENECID | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/1951 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/23/1998 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 01/11/1995 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1994 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1994 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1989 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1988 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1998 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 05/12/1988 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 05/12/1988 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 05/12/1988 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1982 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1984 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/24/1979 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1979 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/25/1979 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/01/1978 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/22/1978 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1979 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/11/1978 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1977 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/08/1977 | SUPPL-16 |
Label is not available on this site. |
|||
| 06/28/1976 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/28/1976 | SUPPL-14 | Unspecified |
Label is not available on this site. |
نظرات کاربران