| Product NDC: | 63323-321 |
| Proprietary Name: | Polymyxin B |
| Non Proprietary Name: | POLYMYXIN B SULFATE |
| Active Ingredient(s): | 500000 [iU]/1 & nbsp; POLYMYXIN B SULFATE |
| Administration Route(s): | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-321 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA065372 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20091117 |
| Package NDC: | 63323-321-10 |
| Package Description: | 10 VIAL in 1 TRAY (63323-321-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| NDC Code | 63323-321-10 |
| Proprietary Name | Polymyxin B |
| Package Description | 10 VIAL in 1 TRAY (63323-321-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| Product NDC | 63323-321 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | POLYMYXIN B SULFATE |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC |
| Start Marketing Date | 20091117 |
| Marketing Category Name | ANDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | POLYMYXIN B SULFATE |
| Strength Number | 500000 |
| Strength Unit | [iU]/1 |
| Pharmaceutical Classes | Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] |