Acacia
Allergenic Extract
Approved
Approval ID
9e44c782-6ad1-4e86-b333-e9358cbc5867
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2009
Manufacturers
FDA
Nelco Laboratories, Inc.
DUNS: 054980867
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Arroyo Willow
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3097
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Arroyo Willow
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SALIX LASIOLEPIS POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 808UWJ59FI
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
East Sycamore
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3049
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
East Sycamore
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
PLATANUS OCCIDENTALIS POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: E03U1K03LK
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Black Walnut
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3065
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Black Walnut
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
JUGLANS NIGRA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 1BV28146ZR
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Pussy Willow
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3105
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Pussy Willow
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SALIX DISCOLOR POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: ER172J09FM
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
California Black Walnut
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3073
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
California Black Walnut
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
JUGLANS CALIFORNICA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 2147EPR64I
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Balsam Poplar
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3121
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Balsam Poplar
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: H8QYU50Z2D
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Poplar
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3113
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Poplar
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POPULUS DELTOIDES POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 476DVV63WP
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
English Walnut
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3081
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
English Walnut
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
JUGLANS REGIA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: ARW43087I1
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Black Willow
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3089
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Black Willow
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SALIX NIGRA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 6M2JIH93ZN
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
West Sycamore
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3057
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
West Sycamore
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (5)
PLATANUS RACEMOSA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: BWC8DYU8OS
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT