FDA Product

Birch

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

Basic Information

Product Name

Birch

FDA Product Code

36987-2534

Regulatory Information

NDC Product Code

36987-2534

Application Number

BLA102192

Marketing Category

C73585

Effective Date

December 3, 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

BETULA NIGRA POLLEN

Quantity: 10000 [PNU] in 1 mL

Code: 93963RFO1P

Class Code: ACTIB

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

PHENOL

Code: 339NCG44TV

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Active Moieties

BETULA NIGRA POLLEN

Code: 93963RFO1P

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy