Licensed vaccine
Varivax
FDA-licensed vaccine · Merck Sharp & Dohme LLC · STN BL 103552
Key facts
| Trade name | Varivax |
|---|---|
| Proper name | Varicella Virus Vaccine Live |
| Manufacturer | Merck Sharp & Dohme LLC |
| Submission tracking number (STN) | BL 103552 |
| FDA product areas | Biologics, Vaccines |
| Recent FDA documents | August 21, 2023 Approval Letter - VARIVAX, February 27, 2023 Clinical Review Memo - VARIVAX, Statistical Review - VARIVAX, February 27, 2023 Approval Letter - VARIVAX, November 3, 2022 Approval Letter - VARIVAX (refrigerated and frozen formulations), September 15, 2020 Approval Letter - VARIVAX, January 23, 2019 Approval Letter - VARIVAX, October 19, 2018 Approval Letter - VARIVAX, February 16, 2017 Summary Basis for Regulatory Action - VARIVAX, February 17, 2017 Approval Letter - VARIVAX, Patient Information - Varivax (Refrigerator), Patient Information - Varivax (Frozen) |
| FDA page updated | Aug 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: