Standardized Orchard Grass Pollen

Allergenic Extract

Approved

Approval ID

6a9c78b4-97a6-4fbc-a072-8916f7232b1b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 25, 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.

Standardized Timothy Grass Pollen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code36987-2401

Application NumberBLA102202

Product Classification

Marketing Category

C73585

Generic Name

Standardized Timothy Grass Pollen

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 25, 2009

FDA Product Classification

INGREDIENTS (6)

PHLEUM PRATENSE POLLENActive

Quantity: 100000 [BAU] in 1 mL

Code: 65M88RW2EG

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

Standardized Redtop Grass Pollen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code36987-2363

Application NumberBLA102192

Product Classification

Marketing Category

C73585

Generic Name

Standardized Redtop Grass Pollen

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 25, 2009

FDA Product Classification

INGREDIENTS (6)

AGROSTIS GIGANTEA POLLENActive

Quantity: 100000 [BAU] in 1 mL

Code: HU8V6E7HOA

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

Standardized Sweet Vernal Grass Pollen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code36987-2399

Application NumberBLA102201

Product Classification

Marketing Category

C73585

Generic Name

Standardized Sweet Vernal Grass Pollen

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 25, 2009

FDA Product Classification

INGREDIENTS (6)

ANTHOXANTHUM ODORATUM POLLENActive

Quantity: 100000 [BAU] in 1 mL

Code: 2KIK19R45Y

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

Standardized Meadow Fescue Grass Pollen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code36987-2319

Application NumberBLA102197

Product Classification

Marketing Category

C73585

Generic Name

Standardized Meadow Fescue Grass Pollen

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 25, 2009

FDA Product Classification

INGREDIENTS (6)

FESTUCA PRATENSIS POLLENActive

Quantity: 100000 [BAU] in 1 mL

Code: A0WFQ8P6N1

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

Standardized Perennial Rye Grass Pollen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code36987-2389

Application NumberBLA102200

Product Classification

Marketing Category

C73585

Generic Name

Standardized Perennial Rye Grass Pollen

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 25, 2009

FDA Product Classification

INGREDIENTS (6)

LOLIUM PERENNE POLLENActive

Quantity: 100000 [BAU] in 1 mL

Code: 4T81LB52R0

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

Standardized Kentucky (June) Bluegrass Pollen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code36987-2427

Application NumberBLA102196

Product Classification

Marketing Category

C73585

Generic Name

Standardized Kentucky (June) Bluegrass Pollen

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 25, 2009

FDA Product Classification

INGREDIENTS (6)

POA PRATENSIS POLLENActive

Quantity: 100000 [BAU] in 1 mL

Code: SCB8J7LS3T

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

Standardized Timothy Grass Pollen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code36987-2402

Application NumberBLA102202

Product Classification

Marketing Category

C73585

Generic Name

Standardized Timothy Grass Pollen

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 25, 2009

FDA Product Classification

INGREDIENTS (8)

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

PHLEUM PRATENSE POLLENActive

Quantity: 10000 [BAU] in 1 mL

Code: 65M88RW2EG

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM PHOSPHATE, DIBASICInactive

Code: GR686LBA74

Classification: IACT

POTASSIUM PHOSPHATE, MONOBASICInactive

Code: 4J9FJ0HL51

Classification: IACT

Standardized Perennial Rye Grass Pollen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code36987-2390

Application NumberBLA102200

Product Classification

Marketing Category

C73585

Generic Name

Standardized Perennial Rye Grass Pollen

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 25, 2009

FDA Product Classification

INGREDIENTS (8)

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

LOLIUM PERENNE POLLENActive

Quantity: 10000 [BAU] in 1 mL

Code: 4T81LB52R0

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM PHOSPHATE, DIBASICInactive

Code: GR686LBA74

Classification: IACT

POTASSIUM PHOSPHATE, MONOBASICInactive

Code: 4J9FJ0HL51

Classification: IACT

Standardized Kentucky (June) Bluegrass Pollen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code36987-2428

Application NumberBLA102196

Product Classification

Marketing Category

C73585

Generic Name

Standardized Kentucky (June) Bluegrass Pollen

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 25, 2009

FDA Product Classification

INGREDIENTS (8)

POA PRATENSIS POLLENActive

Quantity: 10000 [BAU] in 1 mL

Code: SCB8J7LS3T

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM PHOSPHATE, DIBASICInactive

Code: GR686LBA74

Classification: IACT

POTASSIUM PHOSPHATE, MONOBASICInactive

Code: 4J9FJ0HL51

Classification: IACT