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
ALDORIL 15 از شرکت MERCK
New Drug Application (NDA): 013402
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALDORIL 15 | HYDROCHLOROTHIAZIDE; METHYLDOPA | 15MG;250MG | TABLET;ORAL | Discontinued |
None |
No | No |
| ALDORIL 25 | HYDROCHLOROTHIAZIDE; METHYLDOPA | 25MG;250MG | TABLET;ORAL | Discontinued |
None |
No | No |
| ALDORIL D30 | HYDROCHLOROTHIAZIDE; METHYLDOPA | 30MG;500MG | TABLET;ORAL | Discontinued |
None |
No | No |
| ALDORIL D50 | HYDROCHLOROTHIAZIDE; METHYLDOPA | 50MG;500MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/20/1962 | 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 |
|---|---|---|---|---|---|
| 12/14/2004 | SUPPL-85 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13402s085ltr.pdf |
|
| 04/05/2002 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1998 | SUPPL-82 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 08/05/1997 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 11/29/1995 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1994 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1994 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 03/24/1993 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 09/17/1992 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 09/13/1990 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 12/18/1992 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 04/21/1988 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 04/26/1988 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1987 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 06/02/1986 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 10/24/1985 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 01/17/1985 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1984 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 08/13/1984 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 04/03/1984 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 04/10/1984 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/23/1984 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1983 | SUPPL-60 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/01/1983 | SUPPL-59 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1982 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1982 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 05/08/1987 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 10/14/1981 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 06/17/1981 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/11/1981 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 04/09/1981 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1981 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1981 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1980 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/11/1980 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 01/03/1980 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 03/09/1979 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1981 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1978 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1978 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1978 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/25/1977 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1978 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 09/13/1977 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/13/1977 | SUPPL-35 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/13/1977 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 02/15/1978 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/09/1976 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/1976 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/19/1976 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/12/1975 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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