Licensed vaccine
Engerix-B
FDA-licensed vaccine · GlaxoSmithKline Biologicals · STN 103239
Key facts
| Trade name | Engerix-B |
|---|---|
| Proper name | Hepatitis B Vaccine (Recombinant) |
| Manufacturer | GlaxoSmithKline Biologicals |
| Submission tracking number (STN) | 103239 |
| FDA product areas | Biologics, Vaccines |
| Recent FDA documents | October 27, 2023 Approval Letter - ENGERIX-B, December 19, 2018 Approval Letter - Engerix-B, Package Insert - ENGERIX-B, Supporting Documents older than three years-ENGERIX-B |
| FDA page updated | Oct 30, 2023 |
| 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: