Application 020027
- Type
- NDA
- Sponsor
- BIOVAIL LABS INTL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARDIZEM | DILTIAZEM HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | CARDIZEM | DILTIAZEM HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 1913 | SUPPL | 2004-12-30 |