| NDC Code | 53002-9001-1 |
|---|
| Package Description | 10 mL in 1 BOTTLE, PLASTIC (53002-9001-1) |
|---|
| Product NDC | 53002-9001 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Neomycin And Polymyxin B Sulfates And Hydrocortisone |
|---|
| Non-Proprietary Name | Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone |
|---|
| Dosage Form | SUSPENSION |
|---|
| Usage | AURICULAR (OTIC) |
|---|
| Start Marketing Date | 20030317 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA062488 |
|---|
| Manufacturer | RPK Pharmaceuticals, Inc. |
|---|
| Substance Name | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
|---|
| Strength | 10; 3.5; 10000 |
|---|
| Strength Unit | mg/mL; mg/mL; [USP'U]/mL |
|---|
| Pharmacy Classes | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
|---|