Application 021968
- Type
- NDA
- Sponsor
- CPPI CV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUTENT | SUNITINIB MALATE | CAPSULE; ORAL | EQ 12.5MG BASE | No | No |
| 002 | SUTENT | SUNITINIB MALATE | CAPSULE; ORAL | EQ 25MG BASE | No | No |
| 003 | SUTENT | SUNITINIB MALATE | CAPSULE; ORAL | EQ 50MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 28936 | SUPPL | 2007-02-12 |
| 28935 | SUPPL | 2007-02-12 |
| 28934 | SUPPL | 2007-02-12 |
| 6551 | SUPPL | 2007-02-12 |
| 6550 | SUPPL | 2007-02-12 |
| 37963 | SUPPL | 2007-02-05 |
| 37962 | SUPPL | 2007-02-05 |
| 16652 | SUPPL | 2007-02-05 |
| 16651 | SUPPL | 2007-02-05 |
| 16650 | SUPPL | 2007-02-05 |
| 42365 | SUPPL | 2007-02-02 |
| 42364 | SUPPL | 2007-02-02 |
| 21889 | SUPPL | 2007-02-02 |
| 21888 | SUPPL | 2007-02-02 |
| 21887 | SUPPL | 2007-02-02 |
| 42363 | ORIG | 2006-04-06 |
| 6549 | ORIG | 2006-01-30 |
| 37961 | ORIG | 2006-01-26 |