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Rotateq

Rotavirus Vaccine, Live, Oral, Pentavalent

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Rotateq

Proper name

Rotavirus Vaccine, Live, Oral, Pentavalent

Licence type

351(a)

BLA number

125122

Applicant

Merck Sharp & Dohme LLC

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
2.2X10E6 IU	Suspension	Oral	Tube	Rx	February 3, 2006
2.2X10E6 IU	Suspension	Oral	Ampule	Rx	February 3, 2006

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