MedPath

Bahia Grass

Allergenic Extract

Approved
Approval ID

394c5437-08b9-49ae-a90c-2c5d5b449344

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 4, 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.

Soft Cheat Brome

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2431
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Soft Cheat Brome
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

BROMUS INERMIS POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 766QT72BK6
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT

West Wheat Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2421
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
West Wheat Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

PASCOPYRUM SMITHII POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 6AU0ZD8T1O
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Smooth Brome

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2439
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Smooth Brome
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

BROMUS INERMIS POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 766QT72BK6
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Cultivated Wheat

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2413
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cultivated Wheat
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRITICUM AESTIVUM POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: F1KAH8374D
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Corn Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2305
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Corn Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

ZEA MAYS POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 74PD8J616H
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Italian Rye Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2383
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Italian Rye Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

LOLIUM PERENNE SSP. MULTIFLORUM POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: VJI0WKK736
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Canary Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2297
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Canary Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHALARIS ARUNDINACEA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: FAY1Y90VJ9
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Johnson Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2331
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Johnson Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORGHUM HALEPENSE POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 577VA5B4HP
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Quack Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2357
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Quack Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ELYMUS REPENS POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: ON2T85TA2O
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

Giant Wild Rye

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2375
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Giant Wild Rye
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

LEYMUS CONDENSATUS POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 257GC6QO0Q
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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