DigiFab - 0281-0365-10 - (ovine digoxin immune fab)

Alphabetical Index


Drug Information of DigiFab

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)

Labeler Information of DigiFab

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 Information of DigiFab

Package NDC: 0281-0365-10
Package Description: 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0281-0365-10)

NDC Information of DigiFab

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]

Complete Information of DigiFab


General Information