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FDA Product

Treatment Set TS345463

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

Basic Information

Treatment Set TS345463

49288-0848

Regulatory Information

49288-0848

BLA102223

C73585

May 11, 2012

USA

ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

030705628

Active Ingredients

CYNODON DACTYLON POLLEN

Quantity: 16 [BAU] in 1 mL

Code: 175F461W10

Class Code: ACTIB

CARYA ILLINOINENSIS POLLEN

Quantity: 0.001 g in 1 mL

Code: PYO4JR720Y

Class Code: ACTIB

AMARANTHUS RETROFLEXUS POLLEN

Quantity: 0.002 g in 1 mL

Code: 73B14PX5FW

Class Code: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLEN

Quantity: 160 [AU] in 1 mL

Code: K20Y81ACO3

Class Code: ACTIB

CARYA TOMENTOSA POLLEN

Quantity: 0.001 g in 1 mL

Code: G2A764T54B

Class Code: ACTIB

RUMEX ACETOSELLA POLLEN

Quantity: 0.0004 g in 1 mL

Code: N52MIQ81ZW

Class Code: ACTIB

PERIPLANETA AMERICANA

Quantity: 0.002 g in 1 mL

Code: 2RQ1L9N089

Class Code: ACTIB

AVENA SATIVA POLLEN

Quantity: 0.002 g in 1 mL

Code: A7IKY24TR7

Class Code: ACTIB

PASCOPYRUM SMITHII POLLEN

Quantity: 0.0004 g in 1 mL

Code: 6AU0ZD8T1O

Class Code: ACTIB

PHLEUM PRATENSE POLLEN

Quantity: 160 [BAU] in 1 mL

Code: 65M88RW2EG

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

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

AVENA SATIVA POLLEN

Code: A7IKY24TR7

CYNODON DACTYLON POLLEN

Code: 175F461W10

RUMEX ACETOSELLA POLLEN

Code: N52MIQ81ZW

CARYA ILLINOINENSIS POLLEN

Code: PYO4JR720Y

CARYA TOMENTOSA POLLEN

Code: G2A764T54B

AMBROSIA ARTEMISIIFOLIA POLLEN

Code: K20Y81ACO3

AMARANTHUS RETROFLEXUS POLLEN

Code: 73B14PX5FW

PASCOPYRUM SMITHII POLLEN

Code: 6AU0ZD8T1O

PERIPLANETA AMERICANA

Code: 2RQ1L9N089

PHLEUM PRATENSE POLLEN

Code: 65M88RW2EG

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