MedPath

Acacia

Allergenic Extract

Approved
Approval ID

6f5116d1-f99d-47ef-be88-dca38bbe97f4

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.

Black Walnut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3064
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 (6)

JUGLANS NIGRA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 1BV28146ZR
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Privet

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3024
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Privet
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification

INGREDIENTS (6)

LIGUSTRUM VULGARE POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: Y3FRX92Z0E
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Arroyo Willow

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3096
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 (6)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SALIX LASIOLEPIS POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 808UWJ59FI
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Pussy Willow

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3104
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 (6)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SALIX DISCOLOR POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: ER172J09FM
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

California Black Walnut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3072
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 (6)

JUGLANS CALIFORNICA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 2147EPR64I
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Black Willow

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3088
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 (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SALIX NIGRA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 6M2JIH93ZN
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Poplar

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3112
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 (6)

POPULUS DELTOIDES POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 476DVV63WP
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Balsam Poplar

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3120
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 (6)

POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: H8QYU50Z2D
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Sweet Gum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3040
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sweet Gum
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification

INGREDIENTS (6)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LIQUIDAMBAR STYRACIFLUA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 5Q246DS5BS
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

English Walnut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3080
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 (6)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
JUGLANS REGIA POLLENActive
Quantity: 20000 [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
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

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