Treatment Set TS338618

ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL

Approved

Approval ID

e19139e3-afb3-4224-b931-37ebb68408b3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2010

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 TS339118

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0798

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS339118

Product Specifications

Route of AdministrationINTRADERMAL, SUBCUTANEOUS

Effective DateDecember 1, 2010

FDA Product Classification

INGREDIENTS (23)

CLADOSPORIUM CLADOSPORIOIDESActive

Quantity: 0.00008 g in 1 mL

Code: 4ZWY20GTGO

Classification: ACTIB

USTILAGO NUDA HORDEIActive

Quantity: 0.0005 g in 1 mL

Code: 9Y53ZS6I82

Classification: ACTIB

USTILAGO MAYDISActive

Quantity: 0.0005 g in 1 mL

Code: 4K7Z7K7SWG

Classification: ACTIB

USTILAGO AVENAEActive

Quantity: 0.0005 g in 1 mL

Code: YIH315U1TU

Classification: ACTIB

ANSER ANSER FEATHERActive

Quantity: 0.00000266 g in 1 mL

Code: 15XI414745

Classification: ACTIB

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

CANIS LUPUS FAMILIARIS HAIRActive

Quantity: 0.00008 g in 1 mL

Code: 05S7L91ZTR

Classification: ACTIB

DERMATOPHAGOIDES FARINAEActive

Quantity: 16 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

ASPERGILLUS FUMIGATUSActive

Quantity: 0.002 g in 1 mL

Code: X88DF51T48

Classification: ACTIB

DERMATOPHAGOIDES PTERONYSSINUSActive

Quantity: 16 [AU] in 1 mL

Code: 57L1Z5378K

Classification: ACTIB

PHOMA DESTRUCTIVAActive

Quantity: 0.002 g in 1 mL

Code: A17SE577FM

Classification: ACTIB

COCHLIOBOLUS SATIVUSActive

Quantity: 0.00008 g in 1 mL

Code: 3LN5B70U4W

Classification: ACTIB

FUSARIUM OXYSPORUMActive

Quantity: 0.002 g in 1 mL

Code: 5398RXP8KU

Classification: ACTIB

PERIPLANETA AMERICANAActive

Quantity: 0.00008 g in 1 mL

Code: 2RQ1L9N089

Classification: ACTIB

PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive

Quantity: 0.00008 g in 1 mL

Code: 3Y1PE1GCIG

Classification: ACTIB

AUREOBASIDIUM PULLULANS VAR. PULLUTANSActive

Quantity: 0.01 g in 1 mL

Code: D1A2NG69CK

Classification: ACTIB

GALLUS GALLUS FEATHERActive

Quantity: 0.0000266 g in 1 mL

Code: 1FCM16V0FV

Classification: ACTIB

USTILAGO TRITICIActive

Quantity: 0.0005 g in 1 mL

Code: BV82OL2IZ8

Classification: ACTIB

ANAS PLATYRHYNCHOS FEATHERActive

Quantity: 0.0000266 g in 1 mL

Code: 83B65P4796

Classification: ACTIB

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

Treatment Set TS338909

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0796

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS338909

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateDecember 1, 2010

FDA Product Classification

INGREDIENTS (23)

SORGHUM HALEPENSE POLLENActive

Quantity: 0.000016 g in 1 mL

Code: 577VA5B4HP

Classification: ACTIB

KOCHIA SCOPARIA POLLENActive

Quantity: 0.000016 g in 1 mL

Code: 07A108ZKW5

Classification: ACTIB

USTILAGO CYNODONTISActive

Quantity: 0.000008 g in 1 mL

Code: 0V3J4YEX2W

Classification: ACTIB

SPORISORIUM CRUENTUMActive

Quantity: 0.000008 g in 1 mL

Code: GQM6LVU5V8

Classification: ACTIB

CARYA ALBA POLLENActive

Quantity: 0.000008 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

DERMATOPHAGOIDES FARINAEActive

Quantity: 3.2 [AU] in 1 mL

Code: PR9U2YPF3Q

Classification: ACTIB

JUNIPERUS VIRGINIANA POLLENActive

Quantity: 0.000016 g in 1 mL

Code: PY0JA16R2G

Classification: ACTIB

FRAXINUS AMERICANA POLLENActive

Quantity: 0.000016 g in 1 mL

Code: G684LX721Q

Classification: ACTIB

POA PRATENSIS POLLENActive

Quantity: 32 [BAU] in 1 mL

Code: SCB8J7LS3T

Classification: ACTIB

ALTERNARIA ALTERNATAActive

Quantity: 0.000016 g in 1 mL

Code: 52B29REC7H

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.000016 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

ACER NEGUNDO POLLENActive

Quantity: 0.000016 g in 1 mL

Code: P6K070AR8V

Classification: ACTIB

BETULA NIGRA POLLENActive

Quantity: 0.000016 g in 1 mL

Code: 93963RFO1P

Classification: ACTIB

PLEOSPORA HERBARUMActive

Quantity: 0.000016 g in 1 mL

Code: 0N3Z1P4B2W

Classification: ACTIB

AMBROSIA TRIFIDA POLLENActive

Quantity: 0.0000053 g in 1 mL

Code: KU1V1898XX

Classification: ACTIB

CARYA ILLINOINENSIS POLLENActive

Quantity: 0.000008 g in 1 mL

Code: PYO4JR720Y

Classification: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 0.0000053 g in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

AMBROSIA PSILOSTACHYA POLLENActive

Quantity: 0.0000053 g in 1 mL

Code: RX18M46K8L

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

Treatment Set TS339119

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0799

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS339119

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateDecember 1, 2010

FDA Product Classification

INGREDIENTS (23)

AMBROSIA ARTEMISIIFOLIA POLLENActive

Quantity: 0.0000266 g in 1 mL

Code: K20Y81ACO3

Classification: ACTIB

AMBROSIA PSILOSTACHYA POLLENActive

Quantity: 0.0000266 g in 1 mL

Code: RX18M46K8L

Classification: ACTIB

CYNODON DACTYLON POLLENActive

Quantity: 80 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

POPULUS DELTOIDES POLLENActive

Quantity: 0.00008 g in 1 mL

Code: 476DVV63WP

Classification: ACTIB

BETULA NIGRA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: 93963RFO1P

Classification: ACTIB

FRAXINUS AMERICANA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: G684LX721Q

Classification: ACTIB

QUERCUS ALBA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: Z4Y9ZSV4KK

Classification: ACTIB

CHENOPODIUM ALBUM POLLENActive

Quantity: 0.01 g in 1 mL

Code: 098LKX5NCN

Classification: ACTIB

IVA ANNUA VAR. ANNUA POLLENActive

Quantity: 0.01 g in 1 mL

Code: Y2U5S5PF22

Classification: ACTIB

RUMEX ACETOSELLA POLLENActive

Quantity: 0.002 g in 1 mL

Code: N52MIQ81ZW

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

CARYA ALBA POLLENActive

Quantity: 0.0004 g in 1 mL

Code: G2A764T54B

Classification: ACTIB

CARYA ILLINOINENSIS POLLENActive

Quantity: 0.0004 g in 1 mL

Code: PYO4JR720Y

Classification: ACTIB

AMBROSIA TRIFIDA POLLENActive

Quantity: 0.0000266 g in 1 mL

Code: KU1V1898XX

Classification: ACTIB

ULMUS AMERICANA POLLENActive

Quantity: 0.002 g in 1 mL

Code: 89BAT511BD

Classification: ACTIB

JUNIPERUS VIRGINIANA POLLENActive

Quantity: 0.002 g in 1 mL

Code: PY0JA16R2G

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

SALSOLA KALI POLLENActive

Quantity: 0.002 g in 1 mL

Code: 2MH135KC6G

Classification: ACTIB

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

Treatment Set TS338910

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code49288-0797

Application NumberBLA102223

Product Classification

Marketing Category

C73585

Generic Name

Treatment Set TS338910

Product Specifications

Route of AdministrationSUBCUTANEOUS, INTRADERMAL

Effective DateDecember 1, 2010

FDA Product Classification

INGREDIENTS (17)

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

GALLUS GALLUS FEATHERActive

Quantity: 0.00013 g in 1 mL

Code: 1FCM16V0FV

Classification: ACTIB

ANAS PLATYRHYNCHOS FEATHERActive

Quantity: 0.00013 g in 1 mL

Code: 83B65P4796

Classification: ACTIB

CYNODON DACTYLON POLLENActive

Quantity: 80 [BAU] in 1 mL

Code: 175F461W10

Classification: ACTIB

ANSER ANSER FEATHERActive

Quantity: 0.00013 g in 1 mL

Code: 15XI414745

Classification: ACTIB

USTILAGO NUDA HORDEIActive

Quantity: 0.0001 g in 1 mL

Code: 9Y53ZS6I82

Classification: ACTIB

USTILAGO MAYDISActive

Quantity: 0.0001 g in 1 mL

Code: 4K7Z7K7SWG

Classification: ACTIB

USTILAGO AVENAEActive

Quantity: 0.0001 g in 1 mL

Code: YIH315U1TU

Classification: ACTIB

USTILAGO TRITICIActive

Quantity: 0.0001 g in 1 mL

Code: BV82OL2IZ8

Classification: ACTIB

PERIPLANETA AMERICANAActive

Quantity: 0.00008 g in 1 mL

Code: 2RQ1L9N089

Classification: ACTIB

PHENOLInactive

Code: 339NCG44TV

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

IVA ANNUA VAR. ANNUA POLLENActive

Quantity: 0.00008 g in 1 mL

Code: Y2U5S5PF22

Classification: ACTIB

AMARANTHUS RETROFLEXUS POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 73B14PX5FW

Classification: ACTIB

SALSOLA KALI POLLENActive

Quantity: 0.0004 g in 1 mL

Code: 2MH135KC6G

Classification: ACTIB

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8X

Classification: IACT