BIRCH MIX, RIVER/PAPER/SWEET/WHITE POLLEN

Product NDC

54575-913

11-digit product format

545750913

Labeler code

54575

Product ID

54575-913_dbe7bebd-e445-4e59-8302-e706b795fbde

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

betula nigra pollen and betula papyrifera pollen and betula lenta pollen and betula populifolia pollen

Dosage form

INJECTION, SOLUTION

Route

PERCUTANEOUS; SUBCUTANEOUS

Labeler

Allergy Laboratories, Inc.

Application

BLA101376

Marketing category

BLA

Marketing start

1967-12-07

Marketing end

0000-00-00

Substance

BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA LENTA POLLEN; BETULA POPULIFOLIA POLLEN

Active strength

0 g/20mL; g/20mL; g/20mL; g/20mL

Pharmacologic classes

Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record