Application 062483
- Type
- ANDA
- Sponsor
- VALEANT LUXEMBOURG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GRIFULVIN V | GRISEOFULVIN, MICROSIZE | SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42762 | SUPPL | 2005-07-22 |
| 22264 | SUPPL | 2003-08-05 |
| 22263 | SUPPL | 2003-08-05 |
| 22262 | SUPPL | 2003-08-05 |
| 22261 | SUPPL | 2003-08-05 |
| 22260 | SUPPL | 2003-08-05 |
| 22259 | SUPPL | 2003-08-05 |
| 22258 | SUPPL | 2003-08-05 |
| 42761 | SUPPL | 2003-07-31 |
| 42760 | SUPPL | 2003-07-31 |
| 22269 | SUPPL | 2003-07-31 |
| 22268 | SUPPL | 2003-07-31 |
| 22267 | SUPPL | 2003-07-31 |
| 22266 | SUPPL | 2003-07-31 |
| 22265 | SUPPL | 2003-07-31 |
| 22257 | ORIG | 2003-07-31 |