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