Application 020377
- Type
- NDA
- Sponsor
- WYETH PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CORDARONE | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 2421 | SUPPL | 2006-09-18 |
| 2420 | SUPPL | 2005-09-22 |
| 23579 | ORIG | 2005-07-29 |
| 24863 | SUPPL | 2004-11-08 |
| 2419 | SUPPL | 2004-11-08 |
| 2418 | SUPPL | 2004-11-08 |
| 2416 | SUPPL | 2004-11-08 |
| 24867 | SUPPL | 2004-09-03 |
| 41313 | SUPPL | 2003-08-08 |
| 20618 | SUPPL | 2003-08-08 |
| 24866 | SUPPL | 2003-05-30 |
| 24865 | SUPPL | 2003-05-30 |
| 24864 | SUPPL | 2003-05-30 |
| 2417 | SUPPL | 2003-05-30 |
| 24862 | SUPPL | 2001-07-11 |
| 2415 | SUPPL | 2001-07-11 |