Application 019309
- Type
- NDA
- Sponsor
- BIOVAIL LABS INTL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VASOTEC | ENALAPRILAT | INJECTABLE;INJECTION | 1.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 40889 | SUPPL | 2011-02-15 |
| 20217 | SUPPL | 2011-02-15 |
| 40892 | SUPPL | 2007-07-24 |
| 40890 | SUPPL | 2007-07-24 |
| 20218 | SUPPL | 2007-07-24 |
| 40893 | SUPPL | 2007-07-09 |
| 20222 | SUPPL | 2007-07-09 |
| 20219 | SUPPL | 2007-07-09 |
| 40891 | SUPPL | 2006-10-26 |
| 20221 | SUPPL | 2006-10-26 |
| 20220 | SUPPL | 2006-10-26 |
| 44031 | ORIG | 2006-06-09 |
| 11474 | SUPPL | 2004-06-29 |
| 1282 | SUPPL | 2004-06-29 |
| 17357 | SUPPL | 2002-10-30 |
| 40895 | SUPPL | 2001-11-27 |
| 20223 | SUPPL | 2001-06-22 |
| 40894 | SUPPL | 1997-06-11 |