Product NDC: | 0281-0365 |
Proprietary Name: | DigiFab |
Non Proprietary Name: | ovine digoxin immune fab |
Active Ingredient(s): | 38 mg/1 & nbsp; ovine digoxin immune fab |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0281-0365 |
Labeler Name: | SAVAGE LABORATORIES, A division of Nycomed US Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA103910 |
Marketing Category: | BLA |
Start Marketing Date: | 20010831 |
Package NDC: | 0281-0365-10 |
Package Description: | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0281-0365-10) |
NDC Code | 0281-0365-10 |
Proprietary Name | DigiFab |
Package Description | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0281-0365-10) |
Product NDC | 0281-0365 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | ovine digoxin immune fab |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20010831 |
Marketing Category Name | BLA |
Labeler Name | SAVAGE LABORATORIES, A division of Nycomed US Inc. |
Substance Name | OVINE DIGOXIN IMMUNE FAB |
Strength Number | 38 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Immunoglobulin G [EPC],Digoxin Binding Activity [MoA],Immunoglobulins [Chemical/Ingredient] |