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] |