| NDC Code | 53217-305-01 |
| Package Description | 10 mL in 1 BOTTLE, PLASTIC (53217-305-01) |
| Product NDC | 53217-305 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Polymyxin B Sulfate And Trimethoprim |
| Non-Proprietary Name | Polymyxin B Sulfate And Trimethoprim |
| Dosage Form | SOLUTION |
| Usage | OPHTHALMIC |
| Start Marketing Date | 20170427 |
| Marketing Category Name | ANDA |
| Application Number | ANDA064211 |
| Manufacturer | Aidarex Pharmaceuticals LLC |
| Substance Name | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
| Strength | 10000; 1 |
| Strength Unit | [USP'U]/mL; mg/mL |
| Pharmacy Classes | Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] |