Licensed vaccine
ROTARIX
FDA-licensed vaccine · GlaxoSmithKline Biologicals · STN BL 125265
Key facts
| Trade name | ROTARIX |
|---|---|
| Proper name | Rotavirus Vaccine, Live, Oral |
| Manufacturer | GlaxoSmithKline Biologicals |
| Submission tracking number (STN) | BL 125265 |
| FDA product areas | Biologics |
| Recent FDA documents | November 4, 2022 Approval Letter - ROTARIX, Package Insert and Patient Information (Squeezable Tube Presentation) - ROTARIX, Package Insert and Patient Information (Vial with Oral Dosing Applicator Presentation and Oral Dosing Applicator Only Presentation) - ROTARI, November 12, 2019 Approval Letter - Rotarix, Approval History, Letters, Reviews, and Related Documents - Rotarix, Supporting Documents older than three years - Rotarix |
| FDA page updated | Nov 7, 2022 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 1–9 Supporting documents
- 1–9 Product information documents
- Yes Document full text searchable in Orca1
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-licensed vaccines
The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.
Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date: