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FDA Product

Treatment Set TS331455

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Treatment Set TS331455

49288-0723

Regulatory Information

49288-0723

BLA102223

C73585

December 2, 2009

USA

ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

030705628

Active Ingredients

AMBROSIA TRIFIDA POLLEN

Quantity: 0.00013 g in 1 mL

Code: KU1V1898XX

Class Code: ACTIB

RUMEX ACETOSELLA POLLEN

Quantity: 0.002 g in 1 mL

Code: N52MIQ81ZW

Class Code: ACTIB

USTILAGO AVENAE

Quantity: 0.0005 g in 1 mL

Code: YIH315U1TU

Class Code: ACTIB

PERIPLANETA AMERICANA

Quantity: 0.002 g in 1 mL

Code: 2RQ1L9N089

Class Code: ACTIB

GALLUS GALLUS FEATHER

Quantity: 0.00067 g in 1 mL

Code: 1FCM16V0FV

Class Code: ACTIB

ANAS PLATYRHYNCHOS FEATHER

Quantity: 0.00067 g in 1 mL

Code: 83B65P4796

Class Code: ACTIB

DERMATOPHAGOIDES FARINAE

Quantity: 400 [AU] in 1 mL

Code: PR9U2YPF3Q

Class Code: ACTIB

DERMATOPHAGOIDES PTERONYSSINUS

Quantity: 400 [AU] in 1 mL

Code: 57L1Z5378K

Class Code: ACTIB

FELIS CATUS HAIR

Quantity: 80 [BAU] in 1 mL

Code: 1564HD0N96

Class Code: ACTIB

ANSER ANSER FEATHER

Quantity: 0.00067 g in 1 mL

Code: 15XI414745

Class Code: ACTIB

CANIS LUPUS FAMILIARIS HAIR

Quantity: 0.002 g in 1 mL

Code: 05S7L91ZTR

Class Code: ACTIB

BETULA NIGRA POLLEN

Quantity: 0.002 g in 1 mL

Code: 93963RFO1P

Class Code: ACTIB

ACER NEGUNDO POLLEN

Quantity: 0.002 g in 1 mL

Code: P6K070AR8V

Class Code: ACTIB

POPULUS DELTOIDES POLLEN

Quantity: 0.002 g in 1 mL

Code: 476DVV63WP

Class Code: ACTIB

QUERCUS ALBA POLLEN

Quantity: 0.002 g in 1 mL

Code: Z4Y9ZSV4KK

Class Code: ACTIB

CARYA ILLINOINENSIS POLLEN

Quantity: 0.001 g in 1 mL

Code: PYO4JR720Y

Class Code: ACTIB

ULMUS AMERICANA POLLEN

Quantity: 0.002 g in 1 mL

Code: 89BAT511BD

Class Code: ACTIB

CARYA ALBA POLLEN

Quantity: 0.001 g in 1 mL

Code: G2A764T54B

Class Code: ACTIB

CHENOPODIUM ALBUM POLLEN

Quantity: 0.002 g in 1 mL

Code: 098LKX5NCN

Class Code: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLEN

Quantity: 0.00013 g in 1 mL

Code: K20Y81ACO3

Class Code: ACTIB

AMBROSIA PSILOSTACHYA POLLEN

Quantity: 0.00013 g in 1 mL

Code: RX18M46K8L

Class Code: ACTIB

SALSOLA KALI POLLEN

Quantity: 0.002 g in 1 mL

Code: 2MH135KC6G

Class Code: ACTIB

PLANTAGO LANCEOLATA POLLEN

Quantity: 0.002 g in 1 mL

Code: DO87T1U2CI

Class Code: ACTIB

CYNODON DACTYLON POLLEN

Quantity: 80 [BAU] in 1 mL

Code: 175F461W10

Class Code: ACTIB

SORGHUM HALEPENSE POLLEN

Quantity: 0.0004 g in 1 mL

Code: 577VA5B4HP

Class Code: ACTIB

POA PRATENSIS POLLEN

Quantity: 800 [BAU] in 1 mL

Code: SCB8J7LS3T

Class Code: ACTIB

ASPERGILLUS FUMIGATUS

Quantity: 0.002 g in 1 mL

Code: X88DF51T48

Class Code: ACTIB

ALTERNARIA ALTERNATA

Quantity: 0.002 g in 1 mL

Code: 52B29REC7H

Class Code: ACTIB

USTILAGO NUDA HORDEI

Quantity: 0.0005 g in 1 mL

Code: 9Y53ZS6I82

Class Code: ACTIB

USTILAGO MAYDIS

Quantity: 0.0005 g in 1 mL

Code: 4K7Z7K7SWG

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

USTILAGO TRITICI

Quantity: 0.0005 g in 1 mL

Code: BV82OL2IZ8

Class Code: ACTIB

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

PHENOL

Code: 339NCG44TV

Class Code: IACT

Active Moieties

GALLUS GALLUS FEATHER

Code: 1FCM16V0FV

PERIPLANETA AMERICANA

Code: 2RQ1L9N089

POPULUS DELTOIDES POLLEN

Code: 476DVV63WP

ANAS PLATYRHYNCHOS FEATHER

Code: 83B65P4796

FELIS CATUS HAIR

Code: 1564HD0N96

DERMATOPHAGOIDES FARINAE

Code: PR9U2YPF3Q

CANIS LUPUS FAMILIARIS HAIR

Code: 05S7L91ZTR

CARYA ILLINOINENSIS POLLEN

Code: PYO4JR720Y

AMBROSIA TRIFIDA POLLEN

Code: KU1V1898XX

BETULA NIGRA POLLEN

Code: 93963RFO1P

QUERCUS ALBA POLLEN

Code: Z4Y9ZSV4KK

ANSER ANSER FEATHER

Code: 15XI414745

DERMATOPHAGOIDES PTERONYSSINUS

Code: 57L1Z5378K

ACER NEGUNDO POLLEN

Code: P6K070AR8V

CARYA ALBA POLLEN

Code: G2A764T54B

CYNODON DACTYLON POLLEN

Code: 175F461W10

SORGHUM HALEPENSE POLLEN

Code: 577VA5B4HP

ULMUS AMERICANA POLLEN

Code: 89BAT511BD

AMBROSIA PSILOSTACHYA POLLEN

Code: RX18M46K8L

RUMEX ACETOSELLA POLLEN

Code: N52MIQ81ZW

AMBROSIA ARTEMISIIFOLIA POLLEN

Code: K20Y81ACO3

CHENOPODIUM ALBUM POLLEN

Code: 098LKX5NCN

PLANTAGO LANCEOLATA POLLEN

Code: DO87T1U2CI

POA PRATENSIS POLLEN

Code: SCB8J7LS3T

SALSOLA KALI POLLEN

Code: 2MH135KC6G

ALTERNARIA ALTERNATA

Code: 52B29REC7H

ASPERGILLUS FUMIGATUS

Code: X88DF51T48

USTILAGO NUDA HORDEI

Code: 9Y53ZS6I82

USTILAGO MAYDIS

Code: 4K7Z7K7SWG

USTILAGO TRITICI

Code: BV82OL2IZ8

USTILAGO AVENAE

Code: YIH315U1TU

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