| NDC Code | 0121-0853-20 |
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| Package Description | 10 CUP, UNIT-DOSE in 1 TRAY (0121-0853-20) / 20 mL in 1 CUP, UNIT-DOSE |
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| Product NDC | 0121-0853 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Sulfamethoxazole And Trimethoprim |
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| Non-Proprietary Name | Sulfamethoxazole And Trimethoprim |
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| Dosage Form | SUSPENSION |
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| Usage | ORAL |
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| Start Marketing Date | 20240805 |
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| Marketing Category Name | NDA |
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| Application Number | NDA018615 |
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| Manufacturer | PAI Holdings, LLC dba PAI Pharma |
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| Substance Name | SULFAMETHOXAZOLE; TRIMETHOPRIM |
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| Strength | 200; 40 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS] |
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