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HepaGam B

These highlights do not include all the information needed to use HepaGam B safely and effectively. See full prescribing information for HepaGam B. HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)], Sterile Solution for Intravenous or Intramuscular Injection Solvent/Detergent Treated and Filtered. Greater than 312 international units per milliliter (Measured potency stamped on the vial label) Initial U.S. Approval: 2006

Approved
Approval ID

b8a28ab4-6b20-47ab-8513-012d47db82f1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 2, 2021

Manufacturers
FDA

Saol Therapeutics Inc.

DUNS: 080040201

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

human hepatitis B virus immune globulin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70257-054
Application NumberBLA125035
Product Classification
M
Marketing Category
C73585
G
Generic Name
human hepatitis B virus immune globulin
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 16, 2020
FDA Product Classification

INGREDIENTS (3)

MALTOSEInactive
Code: XJ6S9RV06F
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULINActive
Quantity: 312 [iU] in 1 mL
Code: XII270YC6M
Classification: ACTIB

human hepatitis B virus immune globulin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70257-053
Application NumberBLA125035
Product Classification
M
Marketing Category
C73585
G
Generic Name
human hepatitis B virus immune globulin
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 16, 2020
FDA Product Classification

INGREDIENTS (3)

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULINActive
Quantity: 312 [iU] in 1 mL
Code: XII270YC6M
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MALTOSEInactive
Code: XJ6S9RV06F
Classification: IACT

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