| NDC Code | 70594-049-01 |
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| Package Description | 1 VIAL, GLASS in 1 CARTON (70594-049-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
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| Product NDC | 70594-049 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Polymyxin B |
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| Non-Proprietary Name | Polymyxin B Sulfate |
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| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
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| Usage | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC |
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| Start Marketing Date | 20181001 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA202766 |
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| Manufacturer | Xellia Pharmaceuticals USA LLC |
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| Substance Name | POLYMYXIN B SULFATE |
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| Strength | 500000 |
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| Strength Unit | [USP'U]/1 |
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| Pharmacy Classes | Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
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