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
ALDOMET از شرکت MERCK
New Drug Application (NDA): 013401
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALDOMET | METHYLDOPATE HYDROCHLORIDE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 12/20/1962 | ORIG-1 | Approval |
Type 2 – New Active Ingredient |
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 |
|---|---|---|---|---|---|
| 08/05/1997 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 08/05/1997 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 11/29/1995 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1994 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 03/24/1993 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 09/13/1990 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 11/06/1989 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 05/11/1987 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 02/22/1985 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 10/11/1984 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/27/1985 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/24/1984 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 09/08/1982 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/06/1989 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 10/14/1981 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/14/1981 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/03/1981 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1981 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/25/1981 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1981 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1981 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/1979 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1978 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1979 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/09/1976 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1976 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/06/1976 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/11/1975 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1975 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/1975 | SUPPL-13 | Unspecified |
Label is not available on this site. |
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