Application 062279
- Type
- ANDA
- Sponsor
- VALEANT LUXEMBOURG
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GRIFULVIN V | GRISEOFULVIN, MICROCRYSTALLINE | TABLET;ORAL | 125MG | No | No |
| 002 | GRIFULVIN V | GRISEOFULVIN, MICROCRYSTALLINE | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 003 | GRIFULVIN V | GRISEOFULVIN, MICROSIZE | TABLET;ORAL | 500MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 18307 | SUPPL | 2014-04-10 |
| 42759 | SUPPL | 2005-07-22 |