| NDC Code | 81665-203-01 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (81665-203-01) / 50 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 81665-203 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Sodium Phenylacetate And Sodium Benzoate |
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| Non-Proprietary Name | Sodium Phenylacetate And Sodium Benzoate |
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| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20250225 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA207096 |
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| Manufacturer | Omnivium Pharmaceuticals LLC |
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| Substance Name | SODIUM BENZOATE; SODIUM PHENYLACETATE |
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| Strength | 100; 100 |
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| Strength Unit | mg/mL; mg/mL |
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| Pharmacy Classes | Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC] |
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