| NDC Code | 
                    49999-378-10 | 
                
                
                    | Proprietary Name | 
                    Polymyxin B Sulfate and Trimethoprim | 
                
                
                    | Package Description | 
                    1 BOTTLE, DROPPER in 1 CARTON (49999-378-10)  > 10 mL in 1 BOTTLE, DROPPER | 
                
                
                    | Product NDC | 
                    49999-378 | 
                
                
                    | Product Type Name | 
                    HUMAN PRESCRIPTION DRUG | 
                
                
                    | Non Proprietary Name | 
                    Polymyxin B Sulfate and Trimethoprim Sulfate | 
                
                
                    | Dosage Form Name | 
                    SOLUTION/ DROPS | 
                
                
                    | Route Name | 
                    OPHTHALMIC | 
                
                
                    | Start Marketing Date | 
                    20120320 | 
                
                
                    | Marketing Category Name | 
                    ANDA | 
                
                
                    | Labeler Name | 
                    Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 
                
                
                    | Substance Name | 
                    POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE | 
                
                
                    | Strength Number | 
                    10000; 1 | 
                
                
                    | Strength Unit | 
                    [USP'U]/mL; mg/mL | 
                
                
                    | Pharmaceutical Classes | 
                    Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA] |