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): 013400
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALDOMET | METHYLDOPA | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| ALDOMET | METHYLDOPA | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| ALDOMET | METHYLDOPA | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 12/20/1962 | 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 |
|---|---|---|---|---|---|
| 09/17/2004 | SUPPL-86 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13400s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13400s086ltr.pdf |
||
| 11/10/1998 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 08/05/1997 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 07/07/1997 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1997 | SUPPL-82 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/05/1997 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 11/30/1995 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1994 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1994 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 09/13/1990 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 04/26/1988 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1987 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 10/22/1985 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 02/22/1985 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 01/17/1985 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/1984 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 04/10/1984 | SUPPL-68 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 12/23/1983 | SUPPL-66 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/01/1983 | SUPPL-65 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1982 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1982 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 04/07/1982 | SUPPL-62 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/11/1987 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 10/14/1981 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 08/28/1981 | SUPPL-58 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/17/1981 | SUPPL-57 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/17/1981 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 08/28/1981 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1981 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1981 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1980 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/07/1982 | SUPPL-51 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/10/1979 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1979 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 03/09/1979 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1978 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/1978 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1978 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1977 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1979 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 06/08/1978 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 08/24/1978 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1977 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/06/1977 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 02/15/1978 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/02/1977 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/07/1977 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 11/09/1976 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/1976 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/09/1976 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1976 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 12/12/1975 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/1976 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/06/1975 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/17/2004 | SUPPL-86 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13400s086lbl.pdf |
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