| NDC Code | 70518-3206-0 |
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| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (70518-3206-0) / 10 mL in 1 BOTTLE, DROPPER |
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| Product NDC | 70518-3206 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Polymyxin B Sulfate And Trimethoprim Sulfate |
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| Non-Proprietary Name | Polymyxin B Sulfate, Trimethoprim Sulfate |
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| Dosage Form | SOLUTION/ DROPS |
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| Usage | OPHTHALMIC |
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| Start Marketing Date | 20210830 |
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| Marketing Category Name | NDA AUTHORIZED GENERIC |
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| Application Number | NDA050567 |
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| Manufacturer | REMEDYREPACK INC. |
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| Substance Name | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
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| Strength | 10000; 1 |
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| Strength Unit | [USP'U]/mL; mg/mL |
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| Pharmacy Classes | Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
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