MedPath

Acacia

Allergenic Extract

Approved
Approval ID

1b238b87-2cc5-4ca8-b714-250574ab5722

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 Willow

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3085
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)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SALIX NIGRA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 6M2JIH93ZN
Classification: ACTIB

Arroyo Willow

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3093
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)

SALIX LASIOLEPIS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 808UWJ59FI
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT

Poplar

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3109
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
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
POPULUS DELTOIDES POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 476DVV63WP
Classification: ACTIB

East Sycamore

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3045
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)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
PLATANUS OCCIDENTALIS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: E03U1K03LK
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Balsam Poplar

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3117
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)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: H8QYU50Z2D
Classification: ACTIB

Black Walnut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3061
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: 10000 [PNU] in 1 mL
Code: 1BV28146ZR
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 Code36987-3101
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)

SALIX DISCOLOR POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: ER172J09FM
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

West Sycamore

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3053
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: 10000 [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

English Walnut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3077
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)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
JUGLANS REGIA POLLENActive
Quantity: 10000 [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

California Black Walnut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3069
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)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
JUGLANS CALIFORNICA POLLENActive
Quantity: 10000 [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

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