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
CARDIZEM SR از شرکت BIOVAIL
New Drug Application (NDA): 019471
Company: BIOVAIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued |
None |
Yes | No |
| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued |
None |
Yes | No |
| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued |
None |
Yes | No |
| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 01/23/1989 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 06/04/2001 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/2003 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 12/03/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1997 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/05/1997 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1996 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/17/1995 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1994 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/14/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1995 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/18/1994 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1994 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/22/1992 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1992 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/01/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/07/1991 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/14/1990 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1990 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/16/1990 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1990 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/08/1989 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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