MedPath
FDA Product

Treatment Set TS128873

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

Basic Information

Treatment Set TS128873

49288-0660

Regulatory Information

49288-0660

BLA102223

C73585

December 2, 2009

USA

ALLERGENIC EXTRACTSINDIVIDUAL TREATMENT VIAL

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

030705628

Active Ingredients

AMBROSIA TRIFIDA POLLEN

Quantity: 0.00125 g in 1 mL

Code: KU1V1898XX

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

AMBROSIA BIDENTATA POLLEN

Quantity: 0.00125 g in 1 mL

Code: M3S672G75O

Class Code: ACTIB

AMARANTHUS PALMERI POLLEN

Quantity: 0.00125 g in 1 mL

Code: 1GH3WV23KH

Class Code: ACTIB

AMARANTHUS RETROFLEXUS POLLEN

Quantity: 0.00125 g in 1 mL

Code: 73B14PX5FW

Class Code: ACTIB

AMARANTHUS SPINOSUS POLLEN

Quantity: 0.00125 g in 1 mL

Code: 380W4HYR6N

Class Code: ACTIB

AMARANTHUS TUBERCULATUS POLLEN

Quantity: 0.00125 g in 1 mL

Code: 92N6W6KO2G

Class Code: ACTIB

KOCHIA SCOPARIA POLLEN

Quantity: 0.005 g in 1 mL

Code: 07A108ZKW5

Class Code: ACTIB

CHENOPODIUM BOTRYS POLLEN

Quantity: 0.00167 g in 1 mL

Code: IVU789297D

Class Code: ACTIB

CHENOPODIUM AMBROSIOIDES POLLEN

Quantity: 0.00167 g in 1 mL

Code: WIB701MW2H

Class Code: ACTIB

IVA ANNUA VAR. ANNUA POLLEN

Quantity: 0.0025 g in 1 mL

Code: Y2U5S5PF22

Class Code: ACTIB

IVA XANTHIFOLIA POLLEN

Quantity: 0.0025 g in 1 mL

Code: V80TPZ0T6J

Class Code: ACTIB

PLANTAGO LANCEOLATA POLLEN

Quantity: 0.005 g in 1 mL

Code: DO87T1U2CI

Class Code: ACTIB

SALSOLA KALI POLLEN

Quantity: 0.005 g in 1 mL

Code: 2MH135KC6G

Class Code: ACTIB

PLATANUS OCCIDENTALIS POLLEN

Quantity: 0.00021 g in 1 mL

Code: E03U1K03LK

Class Code: ACTIB

SALIX NIGRA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 6M2JIH93ZN

Class Code: ACTIB

CARPINUS CAROLINIANA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 9UC4BM3IZ0

Class Code: ACTIB

RUMEX CRISPUS POLLEN

Quantity: 0.0025 g in 1 mL

Code: V825XJG64G

Class Code: ACTIB

FAGUS GRANDIFOLIA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 34X886W1H4

Class Code: ACTIB

RUMEX ACETOSELLA POLLEN

Quantity: 0.0025 g in 1 mL

Code: N52MIQ81ZW

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

CELTIS OCCIDENTALIS POLLEN

Quantity: 0.00021 g in 1 mL

Code: 68R9X9Y96X

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

JUNIPERUS ASHEI POLLEN

Quantity: 0.00021 g in 1 mL

Code: 544F8MEY0Y

Class Code: ACTIB

BETULA PAPYRIFERA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 3538FNV8AY

Class Code: ACTIB

JUNIPERUS VIRGINIANA POLLEN

Quantity: 0.00021 g in 1 mL

Code: PY0JA16R2G

Class Code: ACTIB

ACER RUBRUM POLLEN

Quantity: 0.00021 g in 1 mL

Code: 700NK45C76

Class Code: ACTIB

JUNIPERUS PINCHOTII POLLEN

Quantity: 0.00021 g in 1 mL

Code: S8A4X05W7J

Class Code: ACTIB

MORUS RUBRA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 9LYI4RTZ52

Class Code: ACTIB

CARYA OVATA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 54UN9R2798

Class Code: ACTIB

ACER SACCHARINUM POLLEN

Quantity: 0.00021 g in 1 mL

Code: 95447163DG

Class Code: ACTIB

LIQUIDAMBAR STYRACIFLUA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 5Q246DS5BS

Class Code: ACTIB

AILANTHUS ALTISSIMA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 2A64U81OQ3

Class Code: ACTIB

FRAXINUS AMERICANA POLLEN

Quantity: 0.00021 g in 1 mL

Code: G684LX721Q

Class Code: ACTIB

POPULUS ALBA POLLEN

Quantity: 0.00021 g in 1 mL

Code: VU8C8SB23P

Class Code: ACTIB

MORUS ALBA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 3I9T68187H

Class Code: ACTIB

PHENOL

Code: 339NCG44TV

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

CHENOPODIUM ALBUM POLLEN

Quantity: 0.00167 g in 1 mL

Code: 098LKX5NCN

Class Code: ACTIB

JUGLANS NIGRA POLLEN

Quantity: 0.00021 g in 1 mL

Code: 1BV28146ZR

Class Code: ACTIB

CARYA ALBA POLLEN

Quantity: 0.00021 g in 1 mL

Code: G2A764T54B

Class Code: ACTIB

Active Moieties

AMBROSIA TRIFIDA POLLEN

Code: KU1V1898XX

AMBROSIA BIDENTATA POLLEN

Code: M3S672G75O

AMBROSIA ARTEMISIIFOLIA POLLEN

Code: K20Y81ACO3

AMARANTHUS SPINOSUS POLLEN

Code: 380W4HYR6N

AMBROSIA PSILOSTACHYA POLLEN

Code: RX18M46K8L

AMARANTHUS PALMERI POLLEN

Code: 1GH3WV23KH

CHENOPODIUM BOTRYS POLLEN

Code: IVU789297D

AMARANTHUS RETROFLEXUS POLLEN

Code: 73B14PX5FW

AMARANTHUS TUBERCULATUS POLLEN

Code: 92N6W6KO2G

IVA XANTHIFOLIA POLLEN

Code: V80TPZ0T6J

KOCHIA SCOPARIA POLLEN

Code: 07A108ZKW5

CHENOPODIUM ALBUM POLLEN

Code: 098LKX5NCN

CHENOPODIUM AMBROSIOIDES POLLEN

Code: WIB701MW2H

SALSOLA KALI POLLEN

Code: 2MH135KC6G

PLANTAGO LANCEOLATA POLLEN

Code: DO87T1U2CI

RUMEX ACETOSELLA POLLEN

Code: N52MIQ81ZW

IVA ANNUA VAR. ANNUA POLLEN

Code: Y2U5S5PF22

RUMEX CRISPUS POLLEN

Code: V825XJG64G

PLATANUS OCCIDENTALIS POLLEN

Code: E03U1K03LK

JUGLANS NIGRA POLLEN

Code: 1BV28146ZR

PICEA PUNGENS POLLEN

Code: R9JBC6687X

FAGUS GRANDIFOLIA POLLEN

Code: 34X886W1H4

SALIX NIGRA POLLEN

Code: 6M2JIH93ZN

CARPINUS CAROLINIANA POLLEN

Code: 9UC4BM3IZ0

CELTIS OCCIDENTALIS POLLEN

Code: 68R9X9Y96X

ACER SACCHARUM POLLEN

Code: V38QUQ7861

ACER NEGUNDO POLLEN

Code: P6K070AR8V

PINUS STROBUS POLLEN

Code: TX1ER5UV3T

JUNIPERUS ASHEI POLLEN

Code: 544F8MEY0Y

BETULA PAPYRIFERA POLLEN

Code: 3538FNV8AY

JUNIPERUS VIRGINIANA POLLEN

Code: PY0JA16R2G

MORUS RUBRA POLLEN

Code: 9LYI4RTZ52

JUNIPERUS PINCHOTII POLLEN

Code: S8A4X05W7J

ACER RUBRUM POLLEN

Code: 700NK45C76

ACER SACCHARINUM POLLEN

Code: 95447163DG

CARYA OVATA POLLEN

Code: 54UN9R2798

FRAXINUS AMERICANA POLLEN

Code: G684LX721Q

AILANTHUS ALTISSIMA POLLEN

Code: 2A64U81OQ3

CARYA ALBA POLLEN

Code: G2A764T54B

LIQUIDAMBAR STYRACIFLUA POLLEN

Code: 5Q246DS5BS

POPULUS ALBA POLLEN

Code: VU8C8SB23P

MORUS ALBA POLLEN

Code: 3I9T68187H

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