Treatment Set TS345463

ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL

Approved

Approval ID

40631eff-c151-4f94-ade6-6ad2eaced01a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 11, 2012

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 TS346157

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0854

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS346157

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateMay 11, 2012

FDA Product Classification

INGREDIENTS (12)

DERMATOPHAGOIDES FARINAEActive

Quantity: 1000 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

PHLEUM PRATENSE POLLENActive

Quantity: 4000 [BAU] in 1 mL

Code: 65M88RW2EG

Classification: ACTIB

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 1000 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

CANIS LUPUS FAMILIARIS HAIRActive

Quantity: 0.005 g in 1 mL

Code: 05S7L91ZTR

Classification: ACTIB

CYNODON DACTYLON POLLENActive

Quantity: 1000 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 4000 [AU] in 1 mL

Code: K20Y81ACO3

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

IVA ANNUA POLLENActive

Quantity: 0.005 g in 1 mL

Code: Y2U5S5PF22

Classification: ACTIB

Treatment Set TS345825

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0852

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS345825

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateMay 11, 2012

FDA Product Classification

INGREDIENTS (22)

FELIS CATUS HAIRActive

Quantity: 400 [BAU] in 1 mL

Code: 1564HD0N96

Classification: ACTIB

CYNODON DACTYLON POLLENActive

Quantity: 16 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

POA PRATENSIS POLLENActive

Quantity: 160 [BAU] in 1 mL

Code: SCB8J7LS3T

Classification: ACTIB

SORGHUM HALEPENSE POLLENActive

Quantity: 0.00008 g in 1 mL

Code: 577VA5B4HP

Classification: ACTIB

PLATANUS OCCIDENTALIS POLLENActive

Quantity: 0.0004 g in 1 mL

Code: E03U1K03LK

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

ULMUS AMERICANA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 89BAT511BD

Classification: ACTIB

CARYA TOMENTOSA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

MORUS ALBA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 3I9T68187H

Classification: ACTIB

ACER NEGUNDO POLLENActive

Quantity: 0.0004 g in 1 mL

Code: P6K070AR8V

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 160 [AU] in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

JUNIPERUS ASHEI POLLENActive

Quantity: 0.002 g in 1 mL

Code: 544F8MEY0Y

Classification: ACTIB

SALSOLA KALI POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 2MH135KC6G

Classification: ACTIB

URTICA DIOICA POLLENActive

Quantity: 0.002 g in 1 mL

Code: DNB59M1NVU

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

PLANTAGO LANCEOLATA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: DO87T1U2CI

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

RUMEX ACETOSELLA POLLENActive

Quantity: 0.002 g in 1 mL

Code: N52MIQ81ZW

Classification: ACTIB

Treatment Set TS345784

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0851

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS345784

Product Specifications

Route of AdministrationINTRADERMAL, SUBCUTANEOUS

Effective DateMay 11, 2012

FDA Product Classification

INGREDIENTS (18)

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 400 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

DERMATOPHAGOIDES FARINAEActive

Quantity: 400 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

PHLEUM PRATENSE POLLENActive

Quantity: 160 [BAU] in 1 mL

Code: 65M88RW2EG

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 800 [AU] in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

ACER NEGUNDO POLLENActive

Quantity: 0.0004 g in 1 mL

Code: P6K070AR8V

Classification: ACTIB

FESTUCA PRATENSIS POLLENActive

Quantity: 800 [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: 0.0004 g in 1 mL

Code: A7IKY24TR7

Classification: ACTIB

PASCOPYRUM SMITHII POLLENActive

Quantity: 0.002 g in 1 mL

Code: 6AU0ZD8T1O

Classification: ACTIB

CARYA TOMENTOSA POLLENActive

Quantity: 0.0002 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

FELIS CATUS HAIRActive

Quantity: 400 [BAU] in 1 mL

Code: 1564HD0N96

Classification: ACTIB

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

CARYA ILLINOINENSIS POLLENActive

Quantity: 0.0002 g in 1 mL

Code: PYO4JR720Y

Classification: ACTIB

PERIPLANETA AMERICANAActive

Quantity: 0.00008 g in 1 mL

Code: 2RQ1L9N089

Classification: ACTIB

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

Treatment Set TS345694

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0850

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS345694

Product Specifications

Route of AdministrationINTRADERMAL, SUBCUTANEOUS

Effective DateMay 11, 2012

FDA Product Classification

INGREDIENTS (22)

ALTERNARIA ALTERNATAActive

Quantity: 0.002 g in 1 mL

Code: 52B29REC7H

Classification: ACTIB

CANIS LUPUS FAMILIARIS HAIRActive

Quantity: 0.002 g in 1 mL

Code: 05S7L91ZTR

Classification: ACTIB

FELIS CATUS HAIRActive

Quantity: 80 [BAU] in 1 mL

Code: 1564HD0N96

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 800 [AU] in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 80 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

DERMATOPHAGOIDES FARINAEActive

Quantity: 80 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

CYNODON DACTYLON POLLENActive

Quantity: 400 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

FESTUCA PRATENSIS POLLENActive

Quantity: 4000 [BAU] in 1 mL

Code: A0WFQ8P6N1

Classification: ACTIB

CARYA TOMENTOSA POLLENActive

Quantity: 0.0002 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

CARYA ILLINOINENSIS POLLENActive

Quantity: 0.0002 g in 1 mL

Code: PYO4JR720Y

Classification: ACTIB

RUMEX ACETOSELLA POLLENActive

Quantity: 0.002 g in 1 mL

Code: N52MIQ81ZW

Classification: ACTIB

PHLEUM PRATENSE POLLENActive

Quantity: 4000 [BAU] in 1 mL

Code: 65M88RW2EG

Classification: ACTIB

FRAXINUS AMERICANA POLLENActive

Quantity: 0.002 g in 1 mL

Code: G684LX721Q

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

POPULUS DELTOIDES POLLENActive

Quantity: 0.002 g in 1 mL

Code: 476DVV63WP

Classification: ACTIB

EQUUS CABALLUS HAIRActive

Quantity: 0.00008 g in 1 mL

Code: 4F35XG0149

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

ACER NEGUNDO POLLENActive

Quantity: 0.002 g in 1 mL

Code: P6K070AR8V

Classification: ACTIB

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

Treatment Set TS345883

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0853

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS345883

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateMay 11, 2012

FDA Product Classification

INGREDIENTS (25)

URTICA DIOICA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: DNB59M1NVU

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.002 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

CHENOPODIUM ALBUM POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 098LKX5NCN

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 4000 [AU] in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

RUMEX ACETOSELLA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: N52MIQ81ZW

Classification: ACTIB

PHLEUM PRATENSE POLLENActive

Quantity: 800 [BAU] in 1 mL

Code: 65M88RW2EG

Classification: ACTIB

PASCOPYRUM SMITHII POLLENActive

Quantity: 0.002 g in 1 mL

Code: 6AU0ZD8T1O

Classification: ACTIB

BETULA POPULIFOLIA POLLENActive

Quantity: 0.002 g in 1 mL

Code: 23H70FYJ5U

Classification: ACTIB

ACER NEGUNDO POLLENActive

Quantity: 0.00008 g in 1 mL

Code: P6K070AR8V

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

EQUUS CABALLUS HAIRActive

Quantity: 0.01 g in 1 mL

Code: 4F35XG0149

Classification: ACTIB

CARYA ILLINOINENSIS POLLENActive

Quantity: 0.00004 g in 1 mL

Code: PYO4JR720Y

Classification: ACTIB

CARYA TOMENTOSA POLLENActive

Quantity: 0.00004 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

ALTERNARIA ALTERNATAActive

Quantity: 0.002 g in 1 mL

Code: 52B29REC7H

Classification: ACTIB

FELIS CATUS HAIRActive

Quantity: 400 [BAU] in 1 mL

Code: 1564HD0N96

Classification: ACTIB

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 16 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

PERIPLANETA AMERICANAActive

Quantity: 0.0004 g in 1 mL

Code: 2RQ1L9N089

Classification: ACTIB

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

FRAXINUS AMERICANA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: G684LX721Q

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

Treatment Set TS345476

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0849

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS345476

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateMay 11, 2012

FDA Product Classification

INGREDIENTS (15)

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 4000 g in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

CYNODON DACTYLON POLLENActive

Quantity: 1000 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

CARYA TOMENTOSA POLLENActive

Quantity: 0.005 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

DERMATOPHAGOIDES FARINAEActive

Quantity: 1000 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

FELIS CATUS HAIRActive

Quantity: 400 [BAU] in 1 mL

Code: 1564HD0N96

Classification: ACTIB

PLEOSPORA HERBARUMActive

Quantity: 0.005 g in 1 mL

Code: 0N3Z1P4B2W

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

RUMEX ACETOSELLA POLLENActive

Quantity: 0.005 g in 1 mL

Code: N52MIQ81ZW

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive

Quantity: 0.005 g in 1 mL

Code: 3Y1PE1GCIG

Classification: ACTIB

ALTERNARIA ALTERNATAActive

Quantity: 0.002 g in 1 mL

Code: 52B29REC7H

Classification: ACTIB

ARTEMISIA ABSINTHIUM POLLENActive

Quantity: 0.005 g in 1 mL

Code: 81GS97HVFO

Classification: ACTIB

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT