FDA Product

Standardized Orchard Grass Pollen

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

Basic Information

Product Name

Standardized Orchard Grass Pollen

FDA Product Code

36987-2345

Regulatory Information

NDC Product Code

36987-2345

Application Number

BLA102198

Marketing Category

C73585

Effective Date

November 25, 2009

Territorial Authority

USA

FDA Title

Allergenic Extract

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerNelco Laboratories, Inc.

DUNS Number

054980867

Active Ingredients

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

DACTYLIS GLOMERATA POLLEN

Quantity: 100000 [BAU] in 1 mL

Code: 83N78IDA7P

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

PHENOL

Code: 339NCG44TV

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

Active Moieties

DACTYLIS GLOMERATA POLLEN

Code: 83N78IDA7P

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