MedPath

Bahia Grass

Allergenic Extract

Approved
Approval ID

f2e3f6a5-ca7d-4f37-bc43-6561da39f9bb

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 Code36987-2442
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: 0.05 g in 1 mL
Code: 766QT72BK6
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

West Wheat Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2424
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: 0.05 g 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

Soft Cheat Brome

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2434
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: 0.05 g in 1 mL
Code: 766QT72BK6
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Velvet Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2408
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: 0.05 g in 1 mL
Code: GOA51670YV
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Couch Quack Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2316
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Couch Quack Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

ELYMUS REPENS POLLENActive
Quantity: 0.05 g in 1 mL
Code: ON2T85TA2O
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Corn Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2308
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: 0.05 g in 1 mL
Code: 74PD8J616H
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Johnson Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2334
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 BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SORGHUM HALEPENSE POLLENActive
Quantity: 0.05 g in 1 mL
Code: 577VA5B4HP
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Giant Wild Rye

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2378
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: 0.05 g in 1 mL
Code: 257GC6QO0Q
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Grama Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2326
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Grama Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification

INGREDIENTS (5)

BOUTELOUA GRACILIS POLLENActive
Quantity: 0.05 g in 1 mL
Code: 2XO08315X1
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Quack Grass

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-2360
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)

ELYMUS REPENS POLLENActive
Quantity: 0.05 g in 1 mL
Code: ON2T85TA2O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT

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Bahia Grass - FDA Drug Approval Details