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FDA Approval

HepaGam B

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Saol Therapeutics Inc.
DUNS: 080040201
Effective Date
March 23, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Hepatitis B immune globulin(312 [iU] in 1 mL)

Products2

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

HepaGam B

Product Details

NDC Product Code
70257-052
Application Number
BLA125035
Marketing Category
BLA (C73585)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
January 15, 2019
MALTOSEInactive
Code: XJ6S9RV06FClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
Code: XII270YC6MClass: ACTIBQuantity: 312 [iU] in 1 mL

HepaGam B

Product Details

NDC Product Code
70257-051
Application Number
BLA125035
Marketing Category
BLA (C73585)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
January 15, 2019
Code: XII270YC6MClass: ACTIBQuantity: 312 [iU] in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MALTOSEInactive
Code: XJ6S9RV06FClass: IACT
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