MedPath

Acacia

Allergenic Extract

Approved
Approval ID

573781d0-e50e-42ff-8a46-2292b8107ce7

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.

Poplar

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3116
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 BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
POPULUS DELTOIDES POLLENActive
Quantity: 0.1 g in 1 mL
Code: 476DVV63WP
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
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 Code36987-3124
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
POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLENActive
Quantity: 0.1 g in 1 mL
Code: H8QYU50Z2D
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Sweet Gum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3044
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 (5)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LIQUIDAMBAR STYRACIFLUA POLLENActive
Quantity: 0.1 g in 1 mL
Code: 5Q246DS5BS
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Arroyo Willow

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3100
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: 0.1 g 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

Black Willow

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3092
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: 0.1 g in 1 mL
Code: 6M2JIH93ZN
Classification: ACTIB

White Poplar

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3020
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
White Poplar
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification

INGREDIENTS (5)

POPULUS ALBA POLLENActive
Quantity: 0.1 g in 1 mL
Code: VU8C8SB23P
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

California Black Walnut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3076
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)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
JUGLANS CALIFORNICA POLLENActive
Quantity: 0.1 g in 1 mL
Code: 2147EPR64I
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

English Walnut

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3084
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: 0.1 g in 1 mL
Code: ARW43087I1
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Russian Olive

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-3036
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Russian Olive
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 3, 2009
FDA Product Classification

INGREDIENTS (5)

ELAEAGNUS ANGUSTIFOLIA POLLENActive
Quantity: 0.1 g in 1 mL
Code: 68P4F4M6VD
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 Code36987-3068
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: 0.1 g 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

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