| NDC Code | 66658-113-03 |
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| Package Description | 3 VIAL, SINGLE-USE in 1 CARTON (66658-113-03) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01) |
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| Product NDC | 66658-113 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Kepivance |
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| Non-Proprietary Name | Palifermin |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20230804 |
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| Marketing Category Name | BLA |
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| Application Number | BLA125103 |
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| Manufacturer | Swedish Orphan Biovitrum AB (publ) |
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| Substance Name | PALIFERMIN |
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| Strength | 5.16 |
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| Strength Unit | mg/1.2mL |
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| Pharmacy Classes | Fibroblast Growth Factor 7 [CS], Increased Epithelial Proliferation [PE], Mucocutaneous Epithelial Cell Growth Factor [EPC] |
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