NDC Code | 80803-153-50 |
Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE |
Product NDC | 80803-153 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Fyarro |
Non-Proprietary Name | Sirolimus |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION |
Usage | INTRAVENOUS |
Start Marketing Date | 20211206 |
Marketing Category Name | NDA |
Application Number | NDA213312 |
Manufacturer | Aadi Bioscience |
Substance Name | SIROLIMUS |
Strength | 5 |
Strength Unit | mg/mL |
Pharmacy Classes | Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA] |