NDC Code | 42358-295-01 |
Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Product NDC | 42358-295 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Nulibry |
Non-Proprietary Name | Fosdenopterin Hydrobromide |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Usage | INTRAVENOUS |
Start Marketing Date | 20210330 |
Marketing Category Name | NDA |
Application Number | NDA214018 |
Manufacturer | Sentynl Therapeutics, Inc. |
Substance Name | FOSDENOPTERIN HYDROBROMIDE |
Strength | 9.5 |
Strength Unit | mg/1 |
Pharmacy Classes | Cyclic Pyranopterin Monophosphate [EPC], Cyclic Pyranopterin Monophosphate [EXT] |