Drugs@FDA: FDA-Approved Drugs
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| CARDIZEM | DILTIAZEM HYDROCHLORIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CARDIZEM | DILTIAZEM HYDROCHLORIDE | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
Letter (PDF)
|
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. |