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Odactra

House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Odactra

Proper name

House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract

Licence type

351(a)

BLA number

125592

Applicant

ALK - Abello A/S

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
12 SQ-HDM/ML	Tablet	Sublingual	Blister Pack	Rx	March 1, 2017

Purple Book	FDA	Licence type, presentations, reference product, exclusivity