Application 020828
- Type
- NDA
- Sponsor
- HOFFMANN LA ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FORTOVASE | SAQUINAVIR | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 41725 | ORIG | 2010-03-04 |
| 41727 | SUPPL | 2007-07-27 |
| 41726 | SUPPL | 2007-07-27 |
| 20986 | SUPPL | 2007-07-27 |
| 20985 | SUPPL | 2007-07-27 |
| 43565 | SUPPL | 2005-11-04 |
| 23063 | SUPPL | 2005-11-04 |
| 35431 | SUPPL | 2005-09-14 |
| 25938 | SUPPL | 2005-09-14 |
| 13504 | SUPPL | 2005-09-14 |
| 3442 | SUPPL | 2005-09-14 |
| 23062 | SUPPL | 2004-02-03 |
| 13503 | SUPPL | 2004-01-15 |
| 25937 | SUPPL | 2004-01-14 |
| 35430 | SUPPL | 2002-07-02 |
| 3441 | SUPPL | 2002-07-02 |