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
COMBIPRES از شرکت BOEHRINGER INGELHEIM
New Drug Application (NDA): 017503
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COMBIPRES | CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE | 15MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| COMBIPRES | CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE | 15MG;0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| COMBIPRES | CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE | 15MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 09/03/1974 | ORIG-1 | Approval |
Type 1 – New Molecular Entity and Type 4 – New Combination |
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 |
|---|---|---|---|---|---|
| 09/15/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1991 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/07/1987 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1987 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 04/10/1986 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/02/1985 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/18/1984 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1985 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/1984 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/1984 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/1984 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/09/1983 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1981 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/09/1981 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/28/1980 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/15/1981 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/28/1980 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/28/1980 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/26/1980 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/26/1980 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/31/1979 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/05/1981 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/10/1976 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/17/1977 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/09/1976 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/08/1976 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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