GAMMAGARD LIQUID
STN: BL 125105
Proper Name: Immune Globulin Infusion (Human)
Tradename: GAMMAGARD LIQUID ERC
Manufacturer: Takeda Pharmaceuticals U.S.A., Inc.
Indication:
GAMMAGARD LIQUID is:
- a replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.
Product Information
Supporting Documents
- June 27, 2025 Clinical Review Memo - GAMMAGARD LIQUID
- June 27, 2025 Nonclinical Pharmacology and Toxicology Review - GAMMAGARD LIQUID
- June 27, 2025 Approval Letter - GAMMAGARD LIQUID
- January 26, 2024 Approval Letter - GAMMAGARD LIQUID
- January 26, 2024 Clinical Review Memo - GAMMAGARD LIQUID
- Statistical Review - GAMMAGARD LIQUID
- Preclinical Pharmacology Toxicology Review - GAMMAGARD LIQUID
- Supporting Documents older than three years - Gammagard Liquid