Standardized Orchard Grass Pollen

Basic Information

Product Name

FDA Product Code

36987-2346

Regulatory Information

NDC Product Code

36987-2346

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

Active Ingredients

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

DACTYLIS GLOMERATA POLLEN

Quantity: 10000 [BAU] in 1 mL

Code: 83N78IDA7P

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

PHENOL

Code: 339NCG44TV

Class Code: IACT

POTASSIUM PHOSPHATE, MONOBASIC

Code: 4J9FJ0HL51

Class Code: IACT

SODIUM PHOSPHATE, DIBASIC

Code: GR686LBA74

Class Code: IACT

Active Moieties

DACTYLIS GLOMERATA POLLEN

Code: 83N78IDA7P

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM CHLORIDE

SODIUM BICARBONATE

WATER

GLYCERIN

PHENOL

POTASSIUM PHOSPHATE, MONOBASIC

SODIUM PHOSPHATE, DIBASIC

Active Moieties

DACTYLIS GLOMERATA POLLEN