MedPath

Bahia Grass

Allergenic Extract

Approved
Approval ID

0e31061a-dd28-4932-ae30-f95c3c1f1b11

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.

Cultivated Rye

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2365
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cultivated Rye
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SECALE CEREALE POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: I6KAZ8AO1O
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Cultivated Oat

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2337
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cultivated Oat
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
AVENA SATIVA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: A7IKY24TR7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT

Smooth Brome

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2437
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)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BROMUS INERMIS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 766QT72BK6
Classification: ACTIB

Velvet Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2403
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Velvet Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

DISTICHLIS SPICATA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: GOA51670YV
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Giant Wild Rye

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2373
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)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
LEYMUS CONDENSATUS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 257GC6QO0Q
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Soft Cheat Brome

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2429
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)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BROMUS INERMIS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 766QT72BK6
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Salt Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2391
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Salt Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

DISTICHLIS SPICATA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: GOA51670YV
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 Wheat Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2419
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)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PASCOPYRUM SMITHII POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 6AU0ZD8T1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Cultivated Wheat

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2411
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)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRITICUM AESTIVUM POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: F1KAH8374D
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Johnson Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2329
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)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SORGHUM HALEPENSE POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 577VA5B4HP
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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