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PALFORZIA

These highlights do not include all the information needed to use PALFORZIA safely and effectively. See Full Prescribing Information for PALFORZIA. PALFORZIA [Peanut ( ) Allergen Powder-dnfp] Powder for oral administration Initial U.S. Approval: 2020

Approved
Approval ID

17f5be03-6705-4ac9-b8f3-bc4993ebc0eb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 17, 2023

Manufacturers
FDA

Aimmune Therapeutics

DUNS: 057562771

Products 10

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

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-113
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Effective DateMarch 17, 2023
FDA Product Classification

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-110
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Effective DateMarch 17, 2023
FDA Product Classification

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-107
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Effective DateMarch 17, 2023
FDA Product Classification

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-109
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2023
FDA Product Classification

INGREDIENTS (1)

PEANUTActive
Quantity: 200 mg in 1 1
Code: QE1QX6B99R
Classification: ACTIB

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-111
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2023
FDA Product Classification

INGREDIENTS (1)

PEANUTActive
Quantity: 300 mg in 1 1
Code: QE1QX6B99R
Classification: ACTIB

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-108
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Effective DateMarch 17, 2023
FDA Product Classification

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-106
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2023
FDA Product Classification

INGREDIENTS (1)

PEANUTActive
Quantity: 80 mg in 1 1
Code: QE1QX6B99R
Classification: ACTIB

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-102
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2023
FDA Product Classification

INGREDIENTS (1)

PEANUTActive
Quantity: 6 mg in 1 1
Code: QE1QX6B99R
Classification: ACTIB

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-104
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2023
FDA Product Classification

INGREDIENTS (1)

PEANUTActive
Quantity: 20 mg in 1 1
Code: QE1QX6B99R
Classification: ACTIB

Peanut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71881-105
Application NumberBLA125696
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peanut
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2023
FDA Product Classification

INGREDIENTS (1)

PEANUTActive
Quantity: 40 mg in 1 1
Code: QE1QX6B99R
Classification: ACTIB

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PALFORZIA - FDA Drug Approval Details