Treatment Set TS340987

ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL

Approved

Approval ID

ea1e43ad-632d-4e07-887f-c80f4e9798af

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2011

Manufacturers

FDA

Antigen Laboratories, Inc.

DUNS: 030705628

Products 5

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

Treatment Set TS341474

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0817

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS341474

Product Specifications

Route of AdministrationINTRADERMAL, SUBCUTANEOUS

Effective DateJune 8, 2011

FDA Product Classification

INGREDIENTS (35)

PERIPLANETA AMERICANAActive

Quantity: 0.002 g in 1 mL

Code: 2RQ1L9N089

Classification: ACTIB

AUREOBASIDIUM PULLULANS VAR. PULLUTANSActive

Quantity: 0.002 g in 1 mL

Code: D1A2NG69CK

Classification: ACTIB

USTILAGO AVENAEActive

Quantity: 0.0005 g in 1 mL

Code: YIH315U1TU

Classification: ACTIB

USTILAGO MAYDISActive

Quantity: 0.0005 g in 1 mL

Code: 4K7Z7K7SWG

Classification: ACTIB

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 400 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

CYNODON DACTYLON POLLENActive

Quantity: 16 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

IVA ANNUA POLLENActive

Quantity: 0.002 g in 1 mL

Code: Y2U5S5PF22

Classification: ACTIB

ACER NEGUNDO POLLENActive

Quantity: 0.002 g in 1 mL

Code: P6K070AR8V

Classification: ACTIB

CANIS LUPUS FAMILIARIS HAIRActive

Quantity: 0.002 g in 1 mL

Code: 05S7L91ZTR

Classification: ACTIB

CANDIDA ALBICANSActive

Quantity: 0.00008 g in 1 mL

Code: 4D7G21HDBC

Classification: ACTIB

RHIZOPUS STOLONIFERActive

Quantity: 0.002 g in 1 mL

Code: FEE198DK4Q

Classification: ACTIB

CLADOSPORIUM CLADOSPORIOIDESActive

Quantity: 0.00008 g in 1 mL

Code: 4ZWY20GTGO

Classification: ACTIB

PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive

Quantity: 0.00008 g in 1 mL

Code: 3Y1PE1GCIG

Classification: ACTIB

POPULUS DELTOIDES POLLENActive

Quantity: 0.00008 g in 1 mL

Code: 476DVV63WP

Classification: ACTIB

PHOMA DESTRUCTIVAActive

Quantity: 0.002 g in 1 mL

Code: A17SE577FM

Classification: ACTIB

JUNIPERUS VIRGINIANA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: PY0JA16R2G

Classification: ACTIB

ASPERGILLUS FUMIGATUSActive

Quantity: 0.002 g in 1 mL

Code: X88DF51T48

Classification: ACTIB

ANSER ANSER FEATHERActive

Quantity: 0.0000266 g in 1 mL

Code: 15XI414745

Classification: ACTIB

BETULA NIGRA POLLENActive

Quantity: 0.002 g in 1 mL

Code: 93963RFO1P

Classification: ACTIB

FRAXINUS AMERICANA POLLENActive

Quantity: 0.002 g in 1 mL

Code: G684LX721Q

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.002 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

PLEOSPORA HERBARUMActive

Quantity: 0.002 g in 1 mL

Code: 0N3Z1P4B2W

Classification: ACTIB

SORGHUM HALEPENSE POLLENActive

Quantity: 0.002 g in 1 mL

Code: 577VA5B4HP

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.002 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

GALLUS GALLUS FEATHERActive

Quantity: 0.0000266 g in 1 mL

Code: 1FCM16V0FV

Classification: ACTIB

ANAS PLATYRHYNCHOS FEATHERActive

Quantity: 0.0000266 g in 1 mL

Code: 83B65P4796

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

USTILAGO NUDA HORDEIActive

Quantity: 0.0005 g in 1 mL

Code: 9Y53ZS6I82

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

USTILAGO TRITICIActive

Quantity: 0.0005 g in 1 mL

Code: BV82OL2IZ8

Classification: ACTIB

Treatment Set TS341824

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0818

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS341824

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateJune 8, 2011

FDA Product Classification

INGREDIENTS (33)

SALSOLA KALI POLLENActive

Quantity: 0.0029 g in 1 mL

Code: 2MH135KC6G

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.0029 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FRAXINUS AMERICANA POLLENActive

Quantity: 0.0029 g in 1 mL

Code: G684LX721Q

Classification: ACTIB

SORGHUM HALEPENSE POLLENActive

Quantity: 0.0029 g in 1 mL

Code: 577VA5B4HP

Classification: ACTIB

LOLIUM PERENNE POLLENActive

Quantity: 5882 [BAU] in 1 mL

Code: 4T81LB52R0

Classification: ACTIB

POPULUS DELTOIDES POLLENActive

Quantity: 0.0029 g in 1 mL

Code: 476DVV63WP

Classification: ACTIB

ULMUS AMERICANA POLLENActive

Quantity: 0.0029 g in 1 mL

Code: 89BAT511BD

Classification: ACTIB

PLATANUS OCCIDENTALIS POLLENActive

Quantity: 0.0029 g in 1 mL

Code: E03U1K03LK

Classification: ACTIB

BASSIA SCOPARIA POLLENActive

Quantity: 0.0029 g in 1 mL

Code: 07A108ZKW5

Classification: ACTIB

QUERCUS VIRGINIANA POLLENActive

Quantity: 0.00097 g in 1 mL

Code: 8KDG09A4GO

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.00097 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

JUGLANS NIGRA POLLENActive

Quantity: 0.0029 g in 1 mL

Code: 1BV28146ZR

Classification: ACTIB

PLANTAGO LANCEOLATA POLLENActive

Quantity: 0.0029 g in 1 mL

Code: DO87T1U2CI

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 0.00145 g in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

CYCLACHAENA XANTHIFOLIA POLLENActive

Quantity: 0.00145 g in 1 mL

Code: V80TPZ0T6J

Classification: ACTIB

IVA ANNUA POLLENActive

Quantity: 0.00145 g in 1 mL

Code: Y2U5S5PF22

Classification: ACTIB

QUERCUS RUBRA POLLENActive

Quantity: 0.00097 g in 1 mL

Code: SVW19ET93C

Classification: ACTIB

BETULA LENTA POLLENActive

Quantity: 0.00048 g in 1 mL

Code: JQ5HI5004M

Classification: ACTIB

BETULA PAPYRIFERA POLLENActive

Quantity: 0.00048 g in 1 mL

Code: 3538FNV8AY

Classification: ACTIB

BETULA NIGRA POLLENActive

Quantity: 0.00048 g in 1 mL

Code: 93963RFO1P

Classification: ACTIB

CHENOPODIUM ALBUM POLLENActive

Quantity: 0.0029 g in 1 mL

Code: 098LKX5NCN

Classification: ACTIB

AMBROSIA TRIFIDA POLLENActive

Quantity: 0.00145 g in 1 mL

Code: KU1V1898XX

Classification: ACTIB

ACER SACCHARUM POLLENActive

Quantity: 0.00097 g in 1 mL

Code: V38QUQ7861

Classification: ACTIB

ACER RUBRUM POLLENActive

Quantity: 0.00097 g in 1 mL

Code: 700NK45C76

Classification: ACTIB

ACER SACCHARINUM POLLENActive

Quantity: 0.00097 g in 1 mL

Code: 95447163DG

Classification: ACTIB

BETULA OCCIDENTALIS POLLENActive

Quantity: 0.00048 g in 1 mL

Code: R889N2L976

Classification: ACTIB

BETULA POPULIFOLIA POLLENActive

Quantity: 0.00048 g in 1 mL

Code: 23H70FYJ5U

Classification: ACTIB

BETULA ALLEGHANIENSIS POLLENActive

Quantity: 0.00048 g in 1 mL

Code: 3R393IX840

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

Treatment Set TS341430

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0814

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS341430

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateJune 8, 2011

FDA Product Classification

INGREDIENTS (29)

CHENOPODIUM ALBUM POLLENActive

Quantity: 0.002 g in 1 mL

Code: 098LKX5NCN

Classification: ACTIB

DERMATOPHAGOIDES FARINAEActive

Quantity: 16 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 400 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

RHIZOPUS STOLONIFERActive

Quantity: 0.002 g in 1 mL

Code: FEE198DK4Q

Classification: ACTIB

CANDIDA ALBICANSActive

Quantity: 0.00008 g in 1 mL

Code: 4D7G21HDBC

Classification: ACTIB

COCHLIOBOLUS SATIVUSActive

Quantity: 0.002 g in 1 mL

Code: 3LN5B70U4W

Classification: ACTIB

PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive

Quantity: 0.0004 g in 1 mL

Code: 3Y1PE1GCIG

Classification: ACTIB

SPORISORIUM CRUENTUMActive

Quantity: 0.001 g in 1 mL

Code: GQM6LVU5V8

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

JUNIPERUS VIRGINIANA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: PY0JA16R2G

Classification: ACTIB

ACER NEGUNDO POLLENActive

Quantity: 0.002 g in 1 mL

Code: P6K070AR8V

Classification: ACTIB

SORGHUM HALEPENSE POLLENActive

Quantity: 0.002 g in 1 mL

Code: 577VA5B4HP

Classification: ACTIB

CARYA ILLINOINENSIS POLLENActive

Quantity: 0.001 g in 1 mL

Code: PYO4JR720Y

Classification: ACTIB

CARYA TOMENTOSA POLLENActive

Quantity: 0.001 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

ULMUS AMERICANA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: 89BAT511BD

Classification: ACTIB

POPULUS DELTOIDES POLLENActive

Quantity: 0.002 g in 1 mL

Code: 476DVV63WP

Classification: ACTIB

IVA ANNUA POLLENActive

Quantity: 0.002 g in 1 mL

Code: Y2U5S5PF22

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.002 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

SALSOLA KALI POLLENActive

Quantity: 0.002 g in 1 mL

Code: 2MH135KC6G

Classification: ACTIB

BASSIA SCOPARIA POLLENActive

Quantity: 0.002 g in 1 mL

Code: 07A108ZKW5

Classification: ACTIB

FELIS CATUS HAIRActive

Quantity: 16 [BAU] in 1 mL

Code: 1564HD0N96

Classification: ACTIB

PHOMA DESTRUCTIVAActive

Quantity: 0.002 g in 1 mL

Code: A17SE577FM

Classification: ACTIB

CLADOSPORIUM CLADOSPORIOIDESActive

Quantity: 0.002 g in 1 mL

Code: 4ZWY20GTGO

Classification: ACTIB

AUREOBASIDIUM PULLULANS VAR. PULLUTANSActive

Quantity: 0.002 g in 1 mL

Code: D1A2NG69CK

Classification: ACTIB

USTILAGO CYNODONTISActive

Quantity: 0.001 g in 1 mL

Code: 0V3J4YEX2W

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 TS341451

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0815

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS341451

Product Specifications

Route of AdministrationINTRADERMAL, SUBCUTANEOUS

Effective DateJune 8, 2011

FDA Product Classification

INGREDIENTS (22)

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

ALTERNARIA ALTERNATAActive

Quantity: 0.002 g in 1 mL

Code: 52B29REC7H

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 4000 [AU] in 1 mL

Code: K20Y81ACO3

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

CYNODON DACTYLON POLLENActive

Quantity: 80 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

POA PRATENSIS POLLENActive

Quantity: 32 [BAU] in 1 mL

Code: SCB8J7LS3T

Classification: ACTIB

SPORISORIUM CRUENTUMActive

Quantity: 0.0004 g in 1 mL

Code: GQM6LVU5V8

Classification: ACTIB

ULMUS AMERICANA POLLENActive

Quantity: 0.002 g in 1 mL

Code: 89BAT511BD

Classification: ACTIB

ACER NEGUNDO POLLENActive

Quantity: 0.002 g in 1 mL

Code: P6K070AR8V

Classification: ACTIB

CARYA TOMENTOSA POLLENActive

Quantity: 0.002 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

PLATANUS OCCIDENTALIS POLLENActive

Quantity: 0.002 g in 1 mL

Code: E03U1K03LK

Classification: ACTIB

MORUS ALBA POLLENActive

Quantity: 0.002 g in 1 mL

Code: 3I9T68187H

Classification: ACTIB

PLANTAGO LANCEOLATA POLLENActive

Quantity: 0.002 g in 1 mL

Code: DO87T1U2CI

Classification: ACTIB

SALSOLA KALI POLLENActive

Quantity: 0.002 g in 1 mL

Code: 2MH135KC6G

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

URTICA DIOICA POLLENActive

Quantity: 0.002 g in 1 mL

Code: DNB59M1NVU

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT