FDA Product

Prairie Sage

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

Basic Information

Product Name

Prairie Sage

FDA Product Code

49288-0653

Regulatory Information

NDC Product Code

49288-0653

Application Number

BLA102223

Marketing Category

C73585

Effective Date

November 13, 2009

Territorial Authority

USA

FDA Title

Allergenic Extract

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerAntigen Laboratories, Inc.

DUNS Number

030705628

Active Ingredients

ARTEMISIA FRIGIDA POLLEN

Quantity: 0.05 g in 1 mL

Code: 5AN5LR8L3F

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

ARTEMISIA FRIGIDA POLLEN

Code: 5AN5LR8L3F

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