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FDA Product

Treatment Set TS333938

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

Basic Information

Treatment Set TS333938

49288-0657

Regulatory Information

49288-0657

BLA102223

C73585

December 2, 2009

USA

ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

030705628

Active Ingredients

DERMATOPHAGOIDES PTERONYSSINUS

Quantity: 1000 [AU] in 1 mL

Code: 57L1Z5378K

Class Code: ACTIB

AMBROSIA ARTEMISIIFOLIA POLLEN

Quantity: 0.00125 g in 1 mL

Code: K20Y81ACO3

Class Code: ACTIB

AMBROSIA PSILOSTACHYA POLLEN

Quantity: 0.00125 g in 1 mL

Code: RX18M46K8L

Class Code: ACTIB

IVA XANTHIFOLIA POLLEN

Quantity: 0.0025 g in 1 mL

Code: V80TPZ0T6J

Class Code: ACTIB

AMBROSIA TRIFIDA POLLEN

Quantity: 0.00125 g in 1 mL

Code: KU1V1898XX

Class Code: ACTIB

AMBROSIA BIDENTATA POLLEN

Quantity: 0.00125 g in 1 mL

Code: M3S672G75O

Class Code: ACTIB

IVA ANNUA VAR. ANNUA POLLEN

Quantity: 0.0025 g in 1 mL

Code: Y2U5S5PF22

Class Code: ACTIB

SALSOLA KALI POLLEN

Quantity: 0.005 g in 1 mL

Code: 2MH135KC6G

Class Code: ACTIB

FAGUS GRANDIFOLIA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 34X886W1H4

Class Code: ACTIB

PLANTAGO LANCEOLATA POLLEN

Quantity: 0.005 g in 1 mL

Code: DO87T1U2CI

Class Code: ACTIB

SALIX NIGRA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 6M2JIH93ZN

Class Code: ACTIB

PLATANUS OCCIDENTALIS POLLEN

Quantity: 0.00021 g in 1 mL

Code: E03U1K03LK

Class Code: ACTIB

JUGLANS NIGRA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 1BV28146ZR

Class Code: ACTIB

CARPINUS CAROLINIANA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 9UC4BM3IZ0

Class Code: ACTIB

PICEA PUNGENS POLLEN

Quantity: 0.00021 g in 1 mL

Code: R9JBC6687X

Class Code: ACTIB

ACER NEGUNDO POLLEN

Quantity: 0.00021 g in 1 mL

Code: P6K070AR8V

Class Code: ACTIB

PINUS STROBUS POLLEN

Quantity: 0.00021 g in 1 mL

Code: TX1ER5UV3T

Class Code: ACTIB

ACER SACCHARUM POLLEN

Quantity: 0.00021 g in 1 mL

Code: V38QUQ7861

Class Code: ACTIB

CELTIS OCCIDENTALIS POLLEN

Quantity: 0.00021 g in 1 mL

Code: 68R9X9Y96X

Class Code: ACTIB

BETULA PAPYRIFERA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 3538FNV8AY

Class Code: ACTIB

JUNIPERUS ASHEI POLLEN

Quantity: 0.00021 g in 1 mL

Code: 544F8MEY0Y

Class Code: ACTIB

JUNIPERUS VIRGINIANA POLLEN

Quantity: 0.00021 g in 1 mL

Code: PY0JA16R2G

Class Code: ACTIB

ACER SACCHARINUM POLLEN

Quantity: 0.00021 g in 1 mL

Code: 95447163DG

Class Code: ACTIB

AILANTHUS ALTISSIMA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 2A64U81OQ3

Class Code: ACTIB

LIQUIDAMBAR STYRACIFLUA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 5Q246DS5BS

Class Code: ACTIB

FRAXINUS AMERICANA POLLEN

Quantity: 0.00021 g in 1 mL

Code: G684LX721Q

Class Code: ACTIB

CARYA ALBA POLLEN

Quantity: 0.00021 g in 1 mL

Code: G2A764T54B

Class Code: ACTIB

ASPERGILLUS FLAVUS

Quantity: 0.00025 g in 1 mL

Code: 3J888Y9L13

Class Code: ACTIB

POPULUS ALBA POLLEN

Quantity: 0.00021 g in 1 mL

Code: VU8C8SB23P

Class Code: ACTIB

ALTERNARIA ALTERNATA

Quantity: 0.001 g in 1 mL

Code: 52B29REC7H

Class Code: ACTIB

ASPERGILLUS NIGER VAR. NIGER

Quantity: 0.00025 g in 1 mL

Code: 9IOA40ANG6

Class Code: ACTIB

MORUS ALBA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 3I9T68187H

Class Code: ACTIB

ASPERGILLUS FUMIGATUS

Quantity: 0.00025 g in 1 mL

Code: X88DF51T48

Class Code: ACTIB

ASPERGILLUS REPENS

Quantity: 0.00025 g in 1 mL

Code: SQ89E6LOME

Class Code: ACTIB

FUSARIUM OXYSPORUM

Quantity: 0.001 g in 1 mL

Code: 5398RXP8KU

Class Code: ACTIB

MUCOR RACEMOSUS

Quantity: 0.001 g in 1 mL

Code: 17RH99LQ7G

Class Code: ACTIB

PENICILLIUM CAMEMBERTI

Quantity: 0.00017 g in 1 mL

Code: T069R9OPVG

Class Code: ACTIB

PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM

Quantity: 0.00017 g in 1 mL

Code: 3Y1PE1GCIG

Class Code: ACTIB

PENICILLIUM ITALICUM

Quantity: 0.00017 g in 1 mL

Code: AZJ5XKM7W3

Class Code: ACTIB

PENICILLIUM EXPANSUM

Quantity: 0.00017 g in 1 mL

Code: 1XSC3BB35Z

Class Code: ACTIB

PENICILLIUM ROQUEFORTI

Quantity: 0.00017 g in 1 mL

Code: 7ORP6R724L

Class Code: ACTIB

CYNODON DACTYLON POLLEN

Quantity: 45.5 [BAU] in 1 mL

Code: 175F461W10

Class Code: ACTIB

AUREOBASIDIUM PULLULANS VAR. PULLUTANS

Quantity: 0.001 g in 1 mL

Code: D1A2NG69CK

Class Code: ACTIB

RHIZOPUS STOLONIFER

Quantity: 0.001 g in 1 mL

Code: FEE198DK4Q

Class Code: ACTIB

PHOMA DESTRUCTIVA

Quantity: 0.001 g in 1 mL

Code: A17SE577FM

Class Code: ACTIB

LOLIUM PERENNE POLLEN

Quantity: 454.5 [BAU] in 1 mL

Code: 4T81LB52R0

Class Code: ACTIB

PHLEUM PRATENSE POLLEN

Quantity: 454.5 [BAU] in 1 mL

Code: 65M88RW2EG

Class Code: ACTIB

POA PRATENSIS POLLEN

Quantity: 454.5 [BAU] in 1 mL

Code: SCB8J7LS3T

Class Code: ACTIB

ANTHOXANTHUM ODORATUM POLLEN

Quantity: 454.5 [BAU] in 1 mL

Code: 2KIK19R45Y

Class Code: ACTIB

DACTYLIS GLOMERATA POLLEN

Quantity: 454.5 [BAU] in 1 mL

Code: 83N78IDA7P

Class Code: ACTIB

POA COMPRESSA POLLEN

Quantity: 0.000227 g in 1 mL

Code: 50HCQ1NYV5

Class Code: ACTIB

TYPHA LATIFOLIA POLLEN

Quantity: 0.000227 g in 1 mL

Code: 341PDX5PLM

Class Code: ACTIB

ZEA MAYS POLLEN

Quantity: 0.000227 g in 1 mL

Code: 74PD8J616H

Class Code: ACTIB

TRITICUM AESTIVUM POLLEN

Quantity: 0.000227 g in 1 mL

Code: F1KAH8374D

Class Code: ACTIB

SORGHUM HALEPENSE POLLEN

Quantity: 0.000227 g in 1 mL

Code: 577VA5B4HP

Class Code: ACTIB

PHALARIS ARUNDINACEA POLLEN

Quantity: 0.000227 g in 1 mL

Code: FAY1Y90VJ9

Class Code: ACTIB

ELYMUS REPENS POLLEN

Quantity: 0.000227 g in 1 mL

Code: ON2T85TA2O

Class Code: ACTIB

BROMUS INERMIS POLLEN

Quantity: 0.000227 g in 1 mL

Code: 766QT72BK6

Class Code: ACTIB

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

HOLCUS LANATUS POLLEN

Quantity: 0.000227 g in 1 mL

Code: 70O1TP6H01

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

ACER RUBRUM POLLEN

Quantity: 0.00021 g in 1 mL

Code: 700NK45C76

Class Code: ACTIB

MORUS RUBRA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 9LYI4RTZ52

Class Code: ACTIB

JUNIPERUS PINCHOTII POLLEN

Quantity: 0.00021 g in 1 mL

Code: S8A4X05W7J

Class Code: ACTIB

CARYA OVATA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 54UN9R2798

Class Code: ACTIB

COCHLIOBOLUS SATIVUS

Quantity: 0.001 g in 1 mL

Code: 3LN5B70U4W

Class Code: ACTIB

CLADOSPORIUM CLADOSPORIOIDES

Quantity: 0.001 g in 1 mL

Code: 4ZWY20GTGO

Class Code: ACTIB

AGROSTIS GIGANTEA POLLEN

Quantity: 454.5 [BAU] in 1 mL

Code: HU8V6E7HOA

Class Code: ACTIB

FESTUCA PRATENSIS POLLEN

Quantity: 454.5 [BAU] in 1 mL

Code: A0WFQ8P6N1

Class Code: ACTIB

BROMUS SECALINUS POLLEN

Quantity: 0.000227 g in 1 mL

Code: Q4T1SJ3046

Class Code: ACTIB

SECALE CEREALE POLLEN

Quantity: 0.000227 g in 1 mL

Code: I6KAZ8AO1O

Class Code: ACTIB

ARRHENATHERUM ELATIUS POLLEN

Quantity: 0.000227 g in 1 mL

Code: B55BD1QM4Q

Class Code: ACTIB

PASCOPYRUM SMITHII POLLEN

Quantity: 0.000227 g in 1 mL

Code: 6AU0ZD8T1O

Class Code: ACTIB

PHENOL

Code: 339NCG44TV

Class Code: IACT

SORGHUM BICOLOR SSP. DRUMMONDII POLLEN

Quantity: 0.000227 g in 1 mL

Code: B43R30VP73

Class Code: ACTIB

Active Moieties

DERMATOPHAGOIDES PTERONYSSINUS

Code: 57L1Z5378K

AMBROSIA PSILOSTACHYA POLLEN

Code: RX18M46K8L

SALSOLA KALI POLLEN

Code: 2MH135KC6G

AMBROSIA TRIFIDA POLLEN

Code: KU1V1898XX

IVA XANTHIFOLIA POLLEN

Code: V80TPZ0T6J

IVA ANNUA VAR. ANNUA POLLEN

Code: Y2U5S5PF22

AMBROSIA BIDENTATA POLLEN

Code: M3S672G75O

AMBROSIA ARTEMISIIFOLIA POLLEN

Code: K20Y81ACO3

PLANTAGO LANCEOLATA POLLEN

Code: DO87T1U2CI

PLATANUS OCCIDENTALIS POLLEN

Code: E03U1K03LK

SALIX NIGRA POLLEN

Code: 6M2JIH93ZN

CARPINUS CAROLINIANA POLLEN

Code: 9UC4BM3IZ0

FAGUS GRANDIFOLIA POLLEN

Code: 34X886W1H4

JUGLANS NIGRA POLLEN

Code: 1BV28146ZR

ACER NEGUNDO POLLEN

Code: P6K070AR8V

PINUS STROBUS POLLEN

Code: TX1ER5UV3T

CELTIS OCCIDENTALIS POLLEN

Code: 68R9X9Y96X

PICEA PUNGENS POLLEN

Code: R9JBC6687X

ACER SACCHARUM POLLEN

Code: V38QUQ7861

JUNIPERUS VIRGINIANA POLLEN

Code: PY0JA16R2G

ACER RUBRUM POLLEN

Code: 700NK45C76

JUNIPERUS ASHEI POLLEN

Code: 544F8MEY0Y

BETULA PAPYRIFERA POLLEN

Code: 3538FNV8AY

AILANTHUS ALTISSIMA POLLEN

Code: 2A64U81OQ3

FRAXINUS AMERICANA POLLEN

Code: G684LX721Q

JUNIPERUS PINCHOTII POLLEN

Code: S8A4X05W7J

CARYA OVATA POLLEN

Code: 54UN9R2798

LIQUIDAMBAR STYRACIFLUA POLLEN

Code: 5Q246DS5BS

MORUS RUBRA POLLEN

Code: 9LYI4RTZ52

ACER SACCHARINUM POLLEN

Code: 95447163DG

CARYA ALBA POLLEN

Code: G2A764T54B

ALTERNARIA ALTERNATA

Code: 52B29REC7H

POPULUS ALBA POLLEN

Code: VU8C8SB23P

MORUS ALBA POLLEN

Code: 3I9T68187H

ASPERGILLUS NIGER VAR. NIGER

Code: 9IOA40ANG6

ASPERGILLUS REPENS

Code: SQ89E6LOME

ASPERGILLUS FLAVUS

Code: 3J888Y9L13

FUSARIUM OXYSPORUM

Code: 5398RXP8KU

ASPERGILLUS FUMIGATUS

Code: X88DF51T48

COCHLIOBOLUS SATIVUS

Code: 3LN5B70U4W

MUCOR RACEMOSUS

Code: 17RH99LQ7G

PENICILLIUM CAMEMBERTI

Code: T069R9OPVG

RHIZOPUS STOLONIFER

Code: FEE198DK4Q

CYNODON DACTYLON POLLEN

Code: 175F461W10

AGROSTIS GIGANTEA POLLEN

Code: HU8V6E7HOA

PENICILLIUM EXPANSUM

Code: 1XSC3BB35Z

CLADOSPORIUM CLADOSPORIOIDES

Code: 4ZWY20GTGO

PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM

Code: 3Y1PE1GCIG

PENICILLIUM ITALICUM

Code: AZJ5XKM7W3

PENICILLIUM ROQUEFORTI

Code: 7ORP6R724L

PHOMA DESTRUCTIVA

Code: A17SE577FM

DACTYLIS GLOMERATA POLLEN

Code: 83N78IDA7P

AUREOBASIDIUM PULLULANS VAR. PULLUTANS

Code: D1A2NG69CK

LOLIUM PERENNE POLLEN

Code: 4T81LB52R0

POA COMPRESSA POLLEN

Code: 50HCQ1NYV5

FESTUCA PRATENSIS POLLEN

Code: A0WFQ8P6N1

POA PRATENSIS POLLEN

Code: SCB8J7LS3T

ANTHOXANTHUM ODORATUM POLLEN

Code: 2KIK19R45Y

PHLEUM PRATENSE POLLEN

Code: 65M88RW2EG

TYPHA LATIFOLIA POLLEN

Code: 341PDX5PLM

BROMUS SECALINUS POLLEN

Code: Q4T1SJ3046

SORGHUM HALEPENSE POLLEN

Code: 577VA5B4HP

ZEA MAYS POLLEN

Code: 74PD8J616H

SECALE CEREALE POLLEN

Code: I6KAZ8AO1O

TRITICUM AESTIVUM POLLEN

Code: F1KAH8374D

ELYMUS REPENS POLLEN

Code: ON2T85TA2O

ARRHENATHERUM ELATIUS POLLEN

Code: B55BD1QM4Q

PHALARIS ARUNDINACEA POLLEN

Code: FAY1Y90VJ9

PASCOPYRUM SMITHII POLLEN

Code: 6AU0ZD8T1O

BROMUS INERMIS POLLEN

Code: 766QT72BK6

SORGHUM BICOLOR SSP. DRUMMONDII POLLEN

Code: B43R30VP73

HOLCUS LANATUS POLLEN

Code: 70O1TP6H01

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