NDC Code | 0078-0674-61 |
Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) > 4 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 0078-0674 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hycamtin |
Non-Proprietary Name | Topotecan Hydrochloride |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Usage | INTRAVENOUS |
Start Marketing Date | 20161221 |
Marketing Category Name | NDA |
Application Number | NDA020671 |
Manufacturer | Novartis Pharmaceuticals Corporation |
Substance Name | TOPOTECAN HYDROCHLORIDE |
Strength | 4 |
Strength Unit | mg/4mL |
Pharmacy Classes | Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA] |