MedPath

Bahia Grass

Allergenic Extract

Approved
Approval ID

f826609e-90d3-43e4-a125-ce397fce965f

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.

Smooth Brome

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2438
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 (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BROMUS INERMIS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 766QT72BK6
Classification: ACTIB

Cultivated Wheat

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2412
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 (6)

TRITICUM AESTIVUM POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: F1KAH8374D
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Soft Cheat Brome

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2430
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 (6)

BROMUS INERMIS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 766QT72BK6
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

Salt Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2392
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 (6)

SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DISTICHLIS SPICATA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: GOA51670YV
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

West Wheat Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2420
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 (6)

PASCOPYRUM SMITHII POLLENActive
Quantity: 10000 [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
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Italian Rye Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2382
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 (6)

LOLIUM PERENNE SSP. MULTIFLORUM POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: VJI0WKK736
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Giant Wild Rye

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2374
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 (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LEYMUS CONDENSATUS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 257GC6QO0Q
Classification: ACTIB

Quack Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2356
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 (6)

ELYMUS REPENS POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: ON2T85TA2O
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Annual Blue Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2272
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Annual Blue Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POA ANNUA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: 7U437HHU5C
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Velvet Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2404
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 (6)

DISTICHLIS SPICATA POLLENActive
Quantity: 10000 [PNU] in 1 mL
Code: GOA51670YV
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

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