| Product NDC: | 0078-0626 |
| Proprietary Name: | Afinitor |
| Non Proprietary Name: | everolimus |
| Active Ingredient(s): | 2 mg/1 & nbsp; everolimus |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FOR SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0626 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203985 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120829 |
| Package NDC: | 0078-0626-51 |
| Package Description: | 28 BLISTER PACK in 1 CARTON (0078-0626-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0626-61) |
| NDC Code | 0078-0626-51 |
| Proprietary Name | Afinitor |
| Package Description | 28 BLISTER PACK in 1 CARTON (0078-0626-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0626-61) |
| Product NDC | 0078-0626 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | everolimus |
| Dosage Form Name | TABLET, FOR SUSPENSION |
| Route Name | ORAL |
| Start Marketing Date | 20120829 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | EVEROLIMUS |
| Strength Number | 2 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |