Licensed vaccine
HEPLISAV-B
FDA-licensed vaccine · Dynavax Technologies Corporation · STN 125428
Key facts
| Trade name | HEPLISAV-B |
|---|---|
| Proper name | Hepatitis B Vaccine (Recombinant), Adjuvanted |
| Manufacturer | Dynavax Technologies Corporation |
| Submission tracking number (STN) | 125428 |
| FDA product areas | Biologics |
| Recent FDA documents | September 11, 2024 Approval Letter - HEPLISAV-B, May 8, 2023 Approval Letter - HEPLISAV-B, May 6, 2020 Approval Letter - HEPLISAV-B, March 22, 2018 Approval Letter - HEPLISAV-B, OVRR and OBE Office Directors' Memo, Approval History, Letters, Reviews, and Related Documents - HEPLISAV-B, November 9, 2017 Summary Basis for Regulatory Action - HEPLISAV-B, Demographic Subgroup Information - Hepatitis B Vaccine (Recombinant), Adjuvanted; HEPLISAV-B, November 9, 2017 Approval Letter - HEPLISAV-B, Package Insert - HEPLISAV-B |
| FDA page updated | Sep 12, 2024 |
| 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: