Licensed vaccine
ACAM2000
FDA-licensed vaccine · Emergent Product Development Gaithersburg Inc. · STN BL 125158
Key facts
| Trade name | ACAM2000 |
|---|---|
| Proper name | Smallpox and Mpox (Vaccinia) Vaccine, Live |
| Manufacturer | Emergent Product Development Gaithersburg Inc. |
| Submission tracking number (STN) | BL 125158 |
| FDA product areas | Biologics |
| Recent FDA documents | August 22, 2024 Clinical Review Memo - ACAM2000, Statistical Review - ACAM2000, August 29, 2024 Approval Letter - ACAM2000, May 2, 2017 Approval Letter - ACAM2000To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, August 24, 2015 Risk Evaluation and Mitigation Strategy Release Letter - ACAM2000, Medication Guide - ACAM2000, Package Insert - ACAM2000, Supporting Documents older than three years - ACAM2000 |
| FDA page updated | Aug 30, 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: