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Panzyga

These highlights do not include all the information needed to use PANZYGA safely and effectively. See full prescribing information for PANZYGA. PANZYGA, (immune globulin intravenous, human - ifas) 10% Liquid Preparation Initial U.S. Approval: 2018

Approved
Approval ID

e2cc5ddf-119e-ade3-79c2-c712cfbee099

Product Type

PLASMA DERIVATIVE

Effective Date

Apr 4, 2025

Manufacturers
FDA

Pfizer Laboratories Div Pfizer Inc

DUNS: 134489525

Products 6

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

immune globulin intravenous (human)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0069-1224
Application NumberBLA125587
Product Classification
M
Marketing Category
C73585
G
Generic Name
immune globulin intravenous (human)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 4, 2025
FDA Product Classification

INGREDIENTS (1)

HUMAN IMMUNOGLOBULIN GActive
Quantity: 100 mg in 1 mL
Code: 66Y330CJHS
Classification: ACTIB

immune globulin intravenous (human)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0069-1109
Application NumberBLA125587
Product Classification
M
Marketing Category
C73585
G
Generic Name
immune globulin intravenous (human)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 4, 2025
FDA Product Classification

INGREDIENTS (1)

HUMAN IMMUNOGLOBULIN GActive
Quantity: 100 mg in 1 mL
Code: 66Y330CJHS
Classification: ACTIB

immune globulin intravenous (human)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0069-1415
Application NumberBLA125587
Product Classification
M
Marketing Category
C73585
G
Generic Name
immune globulin intravenous (human)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 4, 2025
FDA Product Classification

INGREDIENTS (1)

HUMAN IMMUNOGLOBULIN GActive
Quantity: 100 mg in 1 mL
Code: 66Y330CJHS
Classification: ACTIB

immune globulin intravenous (human)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0069-1558
Application NumberBLA125587
Product Classification
M
Marketing Category
C73585
G
Generic Name
immune globulin intravenous (human)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 4, 2025
FDA Product Classification

INGREDIENTS (1)

HUMAN IMMUNOGLOBULIN GActive
Quantity: 100 mg in 1 mL
Code: 66Y330CJHS
Classification: ACTIB

immune globulin intravenous (human)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0069-1011
Application NumberBLA125587
Product Classification
M
Marketing Category
C73585
G
Generic Name
immune globulin intravenous (human)
Product Specifications
Route of AdministrationIntravenous
Effective DateApril 4, 2025
FDA Product Classification

INGREDIENTS (1)

HUMAN IMMUNOGLOBULIN GActive
Quantity: 100 mg in 1 mL
Code: 66Y330CJHS
Classification: ACTIB

immune globulin intravenous (human)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0069-1312
Application NumberBLA125587
Product Classification
M
Marketing Category
C73585
G
Generic Name
immune globulin intravenous (human)
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 4, 2025
FDA Product Classification

INGREDIENTS (1)

HUMAN IMMUNOGLOBULIN GActive
Quantity: 100 mg in 1 mL
Code: 66Y330CJHS
Classification: ACTIB

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