Licensed vaccine
VAXELIS
FDA-licensed vaccine · MSP Vaccine Company · STN 125563
Key facts
| Trade name | VAXELIS |
|---|---|
| Proper name | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine |
| Manufacturer | MSP Vaccine Company |
| Submission tracking number (STN) | 125563 |
| FDA product areas | Biologics |
| Recent FDA documents | April 12, 2023 Approval Letter - VAXELIS, October 27, 2020 Approval Letter - VAXELIS, Patient Information - VAXELIS, September 25, 2020 Approval Letter - VAXELIS, May 5, 2020 Approval Letter - VAXELIS, March 23, 2020 Approval Letter - VAXELIS, May 4, 2015 Statistical Review - VAXELIS, Clinical Review - VAXELIS, Approval History, Letters, Reviews, and Related Documents - VAXELIS, December 18, 2018 Summary Basis for Regulatory Action - VAXELIS, December 21, 2018 Approval Letter - VAXELIS, Package Insert - VAXELIS |
| FDA page updated | Apr 13, 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: