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
COLBENEMID از شرکت MERCK
New Drug Application (NDA): 012383
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLBENEMID | COLCHICINE; PROBENECID | 0.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 07/27/1961 | 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 |
|---|---|---|---|---|---|
| 08/18/1994 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1994 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/12/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/12/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/02/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/24/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/10/1979 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1981 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/01/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/30/1979 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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