Application 021335
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLEEVEC | IMATINIB MESYLATE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | GLEEVEC | IMATINIB MESYLATE | CAPSULE;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42106 | SUPPL | 2004-09-29 |
| 21606 | SUPPL | 2004-08-09 |
| 5067 | SUPPL | 2004-06-04 |
| 44117 | ORIG | 2003-12-09 |
| 5068 | SUPPL | 2003-11-25 |
| 27505 | SUPPL | 2003-07-23 |
| 42105 | SUPPL | 2003-07-08 |
| 21605 | SUPPL | 2003-07-08 |
| 36678 | SUPPL | 2003-05-20 |
| 36677 | SUPPL | 2003-04-09 |
| 36679 | SUPPL | 2002-12-20 |
| 36676 | SUPPL | 2002-02-01 |
| 27504 | SUPPL | 2002-02-01 |
| 21604 | ORIG | 2001-05-10 |
| 15209 | ORIG | 2001-05-10 |
| 5066 | ORIG | 2001-05-10 |