Licensed vaccine
SHINGRIX
FDA-licensed vaccine · GlaxoSmithKline Biologicals · STN 125614
Key facts
| Trade name | SHINGRIX |
|---|---|
| Proper name | Zoster Vaccine Recombinant, Adjuvanted |
| Manufacturer | GlaxoSmithKline Biologicals |
| Submission tracking number (STN) | 125614 |
| FDA product areas | Biologics |
| Recent FDA documents | May 22, 2023 Approval Letter - SHINGRIX, Toxicology Review- Shingrix, Clinical Review Memorandum - Shingrix, Statistical Review and Evaluation - Shingrix, July 23, 2021 Approval Letter - SHINGRIX, March 24, 2021 Approval Letter - SHINGRIX, May 17, 2019 Approval Letter - SHINGRIX, September 18, 2018 Approval Letter - SHINGRIX, October 20, 2017 Summary Basis for Regulatory Action - SHINGRIX, Demographic Subgroup Information - Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX), Approval History, Letters, Reviews, and Related Documents - SHINGRIX, Package Insert - SHINGRIX |
| FDA page updated | May 23, 2023 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 10–99 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: