Product NDC: | 0078-0628 |
Proprietary Name: | Afinitor |
Non Proprietary Name: | everolimus |
Active Ingredient(s): | 5 mg/1 & nbsp; everolimus |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FOR SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0628 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA203985 |
Marketing Category: | NDA |
Start Marketing Date: | 20120829 |
Package NDC: | 0078-0628-51 |
Package Description: | 28 BLISTER PACK in 1 CARTON (0078-0628-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0628-61) |
NDC Code | 0078-0628-51 |
Proprietary Name | Afinitor |
Package Description | 28 BLISTER PACK in 1 CARTON (0078-0628-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0628-61) |
Product NDC | 0078-0628 |
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 | 5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |