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Rolvedon

eflapegrastim-xnst

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Rolvedon

Proper name

eflapegrastim-xnst

Licence type

351(a)

BLA number

761148

Applicant

Assertio Specialty Pharmaceuticals, LLC

Center

CDER

Presentations

1

First licensure

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Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
13.2MG/0.6ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	September 9, 2022

Sources for this page

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