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Grastek
Timothy Grass Pollen Allergen Extract
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Grastek
Proper name
Timothy Grass Pollen Allergen Extract
Licence type
351(a)
BLA number
125473
Applicant
ALK - Abello A/S
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2800BAU/TABLET | Tablet | Sublingual | Blister Pack | Rx | April 11, 2014 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |