MedPath
FDA Product

Epicoccum

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

Basic Information

Epicoccum

49288-0187

Regulatory Information

49288-0187

BLA102223

C73585

November 17, 2009

USA

Allergenic Extract

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

030705628

Active Ingredients

EPICOCCUM NIGRUM

Quantity: 0.05 g in 1 mL

Code: 87U156LEN7

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

Active Moieties

EPICOCCUM NIGRUM

Code: 87U156LEN7

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