| Product NDC: | 0078-0438 |
| Proprietary Name: | Gleevec |
| Non Proprietary Name: | imatinib mesylate |
| Active Ingredient(s): | 400 mg/1 & nbsp; imatinib mesylate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0438 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021588 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20010515 |
| Package NDC: | 0078-0438-15 |
| Package Description: | 30 TABLET in 1 BOTTLE (0078-0438-15) |
| NDC Code | 0078-0438-15 |
| Proprietary Name | Gleevec |
| Package Description | 30 TABLET in 1 BOTTLE (0078-0438-15) |
| Product NDC | 0078-0438 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | imatinib mesylate |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20010515 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | IMATINIB MESYLATE |
| Strength Number | 400 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |