MedPath
FDA Product

Birch Mixture

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

Basic Information

Birch Mixture

49288-0056

Regulatory Information

49288-0056

BLA102223

C73585

November 19, 2009

USA

Allergenic Extract

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

030705628

Active Ingredients

BETULA LENTA POLLEN

Quantity: 0.0083 g in 1 mL

Code: JQ5HI5004M

Class Code: ACTIB

BETULA PAPYRIFERA POLLEN

Quantity: 0.0083 g in 1 mL

Code: 3538FNV8AY

Class Code: ACTIB

BETULA POPULIFOLIA POLLEN

Quantity: 0.0083 g in 1 mL

Code: 23H70FYJ5U

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 0.0095 g in 1 mL

Code: 451W47IQ8X

Class Code: IACT

GLYCERIN

Quantity: 0.525 mL in 1 mL

Code: PDC6A3C0OX

Class Code: IACT

SODIUM BICARBONATE

Quantity: 0.0024 g in 1 mL

Code: 8MDF5V39QO

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

BETULA OCCIDENTALIS POLLEN

Quantity: 0.0083 g in 1 mL

Code: R889N2L976

Class Code: ACTIB

BETULA NIGRA POLLEN

Quantity: 0.0083 g in 1 mL

Code: 93963RFO1P

Class Code: ACTIB

BETULA ALLEGHANIENSIS POLLEN

Quantity: 0.0083 g in 1 mL

Code: 3R393IX840

Class Code: ACTIB

Active Moieties

BETULA LENTA POLLEN

Code: JQ5HI5004M

BETULA PAPYRIFERA POLLEN

Code: 3538FNV8AY

BETULA OCCIDENTALIS POLLEN

Code: R889N2L976

BETULA NIGRA POLLEN

Code: 93963RFO1P

BETULA POPULIFOLIA POLLEN

Code: 23H70FYJ5U

BETULA ALLEGHANIENSIS POLLEN

Code: 3R393IX840

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