FDA Product

Botrytis

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

Basic Information

Product Name

Botrytis

FDA Product Code

49288-0039

Regulatory Information

NDC Product Code

49288-0039

Application Number

BLA102223

Marketing Category

C73585

Effective Date

November 17, 2009

Territorial Authority

USA

FDA Title

Allergenic Extract

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerAntigen Laboratories, Inc.

DUNS Number

030705628

Active Ingredients

WATER

Code: 059QF0KO0R

Class Code: IACT

GLYCERIN

Quantity: 0.525 mL in 1 mL

Code: PDC6A3C0OX

Class Code: IACT

BOTRYTIS CINEREA

Quantity: 0.05 g in 1 mL

Code: TBW53313S7

Class Code: ACTIB

SODIUM BICARBONATE

Quantity: 0.0024 g in 1 mL

Code: 8MDF5V39QO

Class Code: IACT

SODIUM CHLORIDE

Quantity: 0.0095 g in 1 mL

Code: 451W47IQ8X

Class Code: IACT

Active Moieties

BOTRYTIS CINEREA

Code: TBW53313S7

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