Application 020460
- Type
- NDA
- Sponsor
- ROCHE PALO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYTOVENE | GANCICLOVIR | CAPSULE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | CYTOVENE | GANCICLOVIR | CAPSULE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 41378 | SUPPL | 1997-12-12 |