Treatment Set TS343825

ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL

Approved

Approval ID

e26adce8-a53d-4d04-ab66-6de34d1e8bc4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 22, 2011

Manufacturers

FDA

Antigen Laboratories, Inc.

DUNS: 030705628

Products 7

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Treatment Set TS344004

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0829

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS344004

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 22, 2011

FDA Product Classification

INGREDIENTS (26)

CARYA ILLINOINENSIS POLLENActive

Quantity: 0.0002 g in 1 mL

Code: PYO4JR720Y

Classification: ACTIB

PHLEUM PRATENSE POLLENActive

Quantity: 800 [BAU] in 1 mL

Code: 65M88RW2EG

Classification: ACTIB

BETULA POPULIFOLIA POLLENActive

Quantity: 0.002 g in 1 mL

Code: 23H70FYJ5U

Classification: ACTIB

POPULUS DELTOIDES POLLENActive

Quantity: 0.002 g in 1 mL

Code: 476DVV63WP

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.002 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 800 [AU] in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

CYNODON DACTYLON POLLENActive

Quantity: 400 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

CARYA TOMENTOSA POLLENActive

Quantity: 0.0002 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

PLANTAGO LANCEOLATA POLLENActive

Quantity: 0.002 g in 1 mL

Code: DO87T1U2CI

Classification: ACTIB

CHENOPODIUM ALBUM POLLENActive

Quantity: 0.002 g in 1 mL

Code: 098LKX5NCN

Classification: ACTIB

URTICA DIOICA POLLENActive

Quantity: 0.002 g in 1 mL

Code: DNB59M1NVU

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.002 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

RUMEX ACETOSELLA POLLENActive

Quantity: 0.002 g in 1 mL

Code: N52MIQ81ZW

Classification: ACTIB

FESTUCA PRATENSIS POLLENActive

Quantity: 4000 [BAU] in 1 mL

Code: A0WFQ8P6N1

Classification: ACTIB

SORGHUM HALEPENSE POLLENActive

Quantity: 0.002 g in 1 mL

Code: 577VA5B4HP

Classification: ACTIB

AVENA SATIVA POLLENActive

Quantity: 0.002 g in 1 mL

Code: A7IKY24TR7

Classification: ACTIB

PASCOPYRUM SMITHII POLLENActive

Quantity: 0.002 g in 1 mL

Code: 6AU0ZD8T1O

Classification: ACTIB

FRAXINUS AMERICANA POLLENActive

Quantity: 0.002 g in 1 mL

Code: G684LX721Q

Classification: ACTIB

ACER NEGUNDO POLLENActive

Quantity: 0.002 g in 1 mL

Code: P6K070AR8V

Classification: ACTIB

JUNIPERUS VIRGINIANA POLLENActive

Quantity: 0.002 g in 1 mL

Code: PY0JA16R2G

Classification: ACTIB

ULMUS AMERICANA POLLENActive

Quantity: 0.002 g in 1 mL

Code: 89BAT511BD

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

Treatment Set TS344005

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0830

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS344005

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 22, 2011

FDA Product Classification

INGREDIENTS (16)

ASPERGILLUS FUMIGATUSActive

Quantity: 0.002 g in 1 mL

Code: X88DF51T48

Classification: ACTIB

COCHLIOBOLUS SATIVUSActive

Quantity: 0.005 g in 1 mL

Code: 3LN5B70U4W

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

FELIS CATUS HAIRActive

Quantity: 80 [BAU] in 1 mL

Code: 1564HD0N96

Classification: ACTIB

CANIS LUPUS FAMILIARIS HAIRActive

Quantity: 0.002 g in 1 mL

Code: 05S7L91ZTR

Classification: ACTIB

PERIPLANETA AMERICANAActive

Quantity: 0.005 g in 1 mL

Code: 2RQ1L9N089

Classification: ACTIB

DERMATOPHAGOIDES FARINAEActive

Quantity: 400 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 400 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

ALTERNARIA ALTERNATAActive

Quantity: 0.002 g in 1 mL

Code: 52B29REC7H

Classification: ACTIB

CLADOSPORIUM HERBARUMActive

Quantity: 0.005 g in 1 mL

Code: O64JF11198

Classification: ACTIB

FUSARIUM OXYSPORUMActive

Quantity: 0.005 g in 1 mL

Code: 5398RXP8KU

Classification: ACTIB

EQUUS CABALLUS HAIRActive

Quantity: 0.0004 g in 1 mL

Code: 4F35XG0149

Classification: ACTIB

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

Treatment Set TS344002

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0827

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS344002

Product Specifications

Route of AdministrationINTRADERMAL, SUBCUTANEOUS

Effective DateNovember 22, 2011

FDA Product Classification

INGREDIENTS (26)

CYNODON DACTYLON POLLENActive

Quantity: 80 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

ACER NEGUNDO POLLENActive

Quantity: 0.0004 g in 1 mL

Code: P6K070AR8V

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

FRAXINUS AMERICANA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: G684LX721Q

Classification: ACTIB

JUNIPERUS VIRGINIANA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: PY0JA16R2G

Classification: ACTIB

POPULUS DELTOIDES POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 476DVV63WP

Classification: ACTIB

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 800 [AU] in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

ULMUS AMERICANA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 89BAT511BD

Classification: ACTIB

PLANTAGO LANCEOLATA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: DO87T1U2CI

Classification: ACTIB

CHENOPODIUM ALBUM POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 098LKX5NCN

Classification: ACTIB

URTICA DIOICA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: DNB59M1NVU

Classification: ACTIB

RUMEX ACETOSELLA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: N52MIQ81ZW

Classification: ACTIB

FESTUCA PRATENSIS POLLENActive

Quantity: 800 [BAU] in 1 mL

Code: A0WFQ8P6N1

Classification: ACTIB

SORGHUM HALEPENSE POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 577VA5B4HP

Classification: ACTIB

AVENA SATIVA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: A7IKY24TR7

Classification: ACTIB

PASCOPYRUM SMITHII POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 6AU0ZD8T1O

Classification: ACTIB

BETULA POPULIFOLIA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 23H70FYJ5U

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

CARYA ILLINOINENSIS POLLENActive

Quantity: 0.0002 g in 1 mL

Code: PYO4JR720Y

Classification: ACTIB

CARYA TOMENTOSA POLLENActive

Quantity: 0.0002 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

PHLEUM PRATENSE POLLENActive

Quantity: 800 [BAU] in 1 mL

Code: 65M88RW2EG

Classification: ACTIB

Treatment Set TS343826

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0825

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS343826

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 22, 2011

FDA Product Classification

INGREDIENTS (24)

SORGHUM HALEPENSE POLLENActive

Quantity: 0.003 g in 1 mL

Code: 577VA5B4HP

Classification: ACTIB

FRAXINUS AMERICANA POLLENActive

Quantity: 0.003 g in 1 mL

Code: G684LX721Q

Classification: ACTIB

PLATANUS OCCIDENTALIS POLLENActive

Quantity: 0.003 g in 1 mL

Code: E03U1K03LK

Classification: ACTIB

AMBROSIA TRIFIDA POLLENActive

Quantity: 0.0015 g in 1 mL

Code: KU1V1898XX

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 0.0015 g in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

ULMUS AMERICANA POLLENActive

Quantity: 0.003 g in 1 mL

Code: 89BAT511BD

Classification: ACTIB

PLANTAGO LANCEOLATA POLLENActive

Quantity: 0.003 g in 1 mL

Code: DO87T1U2CI

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.003 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

SALSOLA KALI POLLENActive

Quantity: 0.003 g in 1 mL

Code: 2MH135KC6G

Classification: ACTIB

KOCHIA SCOPARIA POLLENActive

Quantity: 0.003 g in 1 mL

Code: 07A108ZKW5

Classification: ACTIB

CHENOPODIUM ALBUM POLLENActive

Quantity: 0.003 g in 1 mL

Code: 098LKX5NCN

Classification: ACTIB

LOLIUM PERENNE POLLENActive

Quantity: 6666.67 [BAU] in 1 mL

Code: 4T81LB52R0

Classification: ACTIB

ARTEMISIA VULGARIS POLLENActive

Quantity: 0.003 g in 1 mL

Code: ANT994T71D

Classification: ACTIB

IVA AXILLARIS POLLENActive

Quantity: 0.003 g in 1 mL

Code: 13KFG30UBR

Classification: ACTIB

POPULUS NIGRA POLLENActive

Quantity: 0.0015 g in 1 mL

Code: 0MGE63QPFJ

Classification: ACTIB

POPULUS ALBA POLLENActive

Quantity: 0.0015 g in 1 mL

Code: VU8C8SB23P

Classification: ACTIB

QUERCUS VIRGINIANA POLLENActive

Quantity: 0.001 g in 1 mL

Code: 8KDG09A4GO

Classification: ACTIB

QUERCUS RUBRA POLLENActive

Quantity: 0.001 g in 1 mL

Code: SVW19ET93C

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.001 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

Treatment Set TS344003

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0828

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS344003

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateNovember 22, 2011

FDA Product Classification

INGREDIENTS (14)

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

FELIS CATUS HAIRActive

Quantity: 400 [BAU] in 1 mL

Code: 1564HD0N96

Classification: ACTIB

DERMATOPHAGOIDES FARINAEActive

Quantity: 400 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

ALTERNARIA ALTERNATAActive

Quantity: 0.0004 g in 1 mL

Code: 52B29REC7H

Classification: ACTIB

PERIPLANETA AMERICANAActive

Quantity: 0.002 g in 1 mL

Code: 2RQ1L9N089

Classification: ACTIB

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 80 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

ASPERGILLUS FUMIGATUSActive

Quantity: 0.002 g in 1 mL

Code: X88DF51T48

Classification: ACTIB

COCHLIOBOLUS SATIVUSActive

Quantity: 0.002 g in 1 mL

Code: 3LN5B70U4W

Classification: ACTIB

CLADOSPORIUM HERBARUMActive

Quantity: 0.002 g in 1 mL

Code: O64JF11198

Classification: ACTIB

FUSARIUM OXYSPORUMActive

Quantity: 0.0004 g in 1 mL

Code: 5398RXP8KU

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

Treatment Set TS344001

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0826

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS344001

Product Specifications

Route of AdministrationINTRADERMAL, SUBCUTANEOUS

Effective DateNovember 22, 2011

FDA Product Classification

INGREDIENTS (18)

PASCOPYRUM SMITHII POLLENActive

Quantity: 0.002 g in 1 mL

Code: 6AU0ZD8T1O

Classification: ACTIB

FELIS CATUS HAIRActive

Quantity: 1000 [BAU] in 1 mL

Code: 1564HD0N96

Classification: ACTIB

CANIS LUPUS FAMILIARIS HAIRActive

Quantity: 0.005 g in 1 mL

Code: 05S7L91ZTR

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 800 [AU] in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

PLANTAGO LANCEOLATA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: DO87T1U2CI

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.005 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

FESTUCA PRATENSIS POLLENActive

Quantity: 800 [BAU] in 1 mL

Code: A0WFQ8P6N1

Classification: ACTIB

CYNODON DACTYLON POLLENActive

Quantity: 1000 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

SORGHUM HALEPENSE POLLENActive

Quantity: 0.005 g in 1 mL

Code: 577VA5B4HP

Classification: ACTIB

AVENA SATIVA POLLENActive

Quantity: 0.005 g in 1 mL

Code: A7IKY24TR7

Classification: ACTIB

PHLEUM PRATENSE POLLENActive

Quantity: 800 [BAU] in 1 mL

Code: 65M88RW2EG

Classification: ACTIB

DERMATOPHAGOIDES FARINAEActive

Quantity: 80 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 400 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT