Licensed vaccine
Zostavax
FDA-licensed vaccine · Merck & Co., Inc · STN 125123
Key facts
| Trade name | Zostavax |
|---|---|
| Proper name | Zoster Vaccine, Live, (Oka/Merck) |
| Manufacturer | Merck & Co., Inc |
| Submission tracking number (STN) | 125123 |
| FDA product areas | Biologics |
| Recent FDA documents | February 21, 2019 Approval Letter - Zostavax, Package Insert - Zostavax (Frozen), January 23, 2019 Approval Letter - Zostavax, April 19, 2018 Approval Letter - Zostavax, April 18, 2018 Summary Basis for Regulatory Action - Zostavax, March 21, 2018 Approval Letter - Zostavax, August 3, 2017 Summary Basis for Regulatory Action - ZOSTAVAX, August 3, 2017 Approval Letter - ZOSTAVAX, March 15, 2017 Summary Basis for Regulatory Action - ZOSTAVAX, March 15, 2017 Approval Letter - Zostavax, Patient Information - Zostavax (Refrigerator Stable), Package Insert - Zostavax (Refrigerator Stable) |
| FDA page updated | Dec 26, 2019 |
| 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: