STN: BL 125329Proper Name: Immune Globulin Intravenous (Human)Tradename: GammaplexManufacturer: Bio Products LaboratoryIndication:
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
STN: BL 125329
Proper Name: Immune Globulin Intravenous (Human)
Tradename: Gammaplex
Manufacturer: Bio Products Laboratory
Indication:
Product Information
Supporting Documents
For the treatment of chronic immune thrombocytopenic purpura (ITP)
This letter corrects the storage temperature stated on page 1, paragraph 5.
For the treatment of primary humoral immunodeficiency (PI)
Contact FDA
(800) 835-4709Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448