Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus

Basic Information

Product Name

FDA Product Code

22840-0037

Regulatory Information

NDC Product Code

22840-0037

Application Number

BLA101834

Marketing Category

C73585

Effective Date

October 7, 2019

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use Greer Standardized Mite Extracts safely and effectively. See full prescribing information for Greer Standardized Mite Extracts. Standardized Mite Extract ( ) Standardized Mite Extract ( ) Standardized Mite Extract Mixture ( and ) Solution for percutaneous, intradermal, or subcutaneous administration Initial U.S. Approval: 1987

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

PHENOL

Code: 339NCG44TV

Class Code: IACT

DERMATOPHAGOIDES FARINAE

Quantity: 5000 [AU] in 1 mL

Code: PR9U2YPF3Q

Class Code: ACTIB

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

DERMATOPHAGOIDES PTERONYSSINUS

Quantity: 5000 [AU] in 1 mL

Code: 57L1Z5378K

Class Code: ACTIB

Active Moieties

DERMATOPHAGOIDES PTERONYSSINUS

Code: 57L1Z5378K

DERMATOPHAGOIDES FARINAE

Code: PR9U2YPF3Q

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM CHLORIDE

GLYCERIN

PHENOL

SODIUM BICARBONATE

Active Moieties

DERMATOPHAGOIDES PTERONYSSINUS

DERMATOPHAGOIDES FARINAE