Octagam Immune Globulin (Human)
Octagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.
Approved
Approval ID
810c8752-a7cb-0bce-777d-8539429773c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2009
Manufacturers
FDA
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
DUNS: 301119178
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Immune Globulin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67467-843
Application NumberBLA125062
Product Classification
M
Marketing Category
C73585
G
Generic Name
Immune Globulin
Product Specifications
Route of AdministrationIntravenous
Effective DateSeptember 9, 2009
FDA Product Classification
INGREDIENTS (1)
HUMAN IMMUNOGLOBULIN GActive
Quantity: 50 mg in 1 mL
Code: 66Y330CJHS
Classification: ACTIB