| NDC Code | 45865-839-01 |
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| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (45865-839-01) > 10 mL in 1 BOTTLE, DROPPER |
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| Product NDC | 45865-839 |
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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 | 19970429 |
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| End Marketing Date | 20180228 |
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| Marketing Category Name | NDA AUTHORIZED GENERIC |
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| Application Number | NDA050567 |
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| Manufacturer | Medsource Pharmaceuticals |
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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 | Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] |
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