Licensed vaccine
Hiberix
FDA-licensed vaccine · GlaxoSmithKline Biologicals · STN 125347
Key facts
| Trade name | Hiberix |
|---|---|
| Proper name | Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) |
| Manufacturer | GlaxoSmithKline Biologicals |
| Submission tracking number (STN) | 125347 |
| FDA product areas | Biologics |
| Recent FDA documents | December 20, 2023 Approval Letter - HIBERIX, April 30, 2018 Approval Letter - Hiberix, April 27, 2018 Summary Basis for Regulatory Action - Hiberix, Approval History, Letters, Reviews, and Related Documents - Hiberix, January 14, 2016 Clinical Review - HIBERIX, January 14, 2016 Statistical Review - HIBERIX, Package Insert - Hiberix, Supporting Documents older than three years - Hiberix |
| FDA page updated | Dec 21, 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: