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Rotarix
Rotavirus Vaccine, Live, Oral
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Rotarix
Proper name
Rotavirus Vaccine, Live, Oral
Licence type
351(a)
BLA number
125265
Applicant
GlaxoSmithKline Biologicals
Center
CBER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 106.0CCID50 | Suspension | Oral | Tube | Disc | November 4, 2022 |
| 106.0CCID50 | Suspension | Oral | Oral Applicator | Rx | November 4, 2022 |
| 1ML | For Suspension | Oral | Single-Dose Vial | Disc | April 3, 2008 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |