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 از شرکت BIOVAIL LABS INTL
New Drug Application (NDA): 020027
Company: BIOVAIL LABS INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDIZEM | DILTIAZEM HYDROCHLORIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CARDIZEM | DILTIAZEM HYDROCHLORIDE | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 10/24/1991 | 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-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/2004 | SUPPL-19 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20027s019ltr.pdf |
|
| 02/05/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1997 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/02/1997 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/05/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1996 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/04/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/24/1995 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1995 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1995 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/28/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1994 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/28/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/24/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
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