Licensed vaccine
RotaTeq
FDA-licensed vaccine · Merck Sharp & Dohme Corp · STN BL 125122
Key facts
| Trade name | RotaTeq |
|---|---|
| Proper name | Rotavirus Vaccine, Live, Oral, Pentavalent |
| Manufacturer | Merck Sharp & Dohme Corp |
| Submission tracking number (STN) | BL 125122 |
| FDA product areas | Biologics, Vaccines |
| Recent FDA documents | August 14, 2020 Approval Letter - RotaTeq, February 23, 2017 Approval Letter - RotaTeq, January 26, 2017 Statistical Review - Rota Teq, February 23, 2017 Clinical Review - Rota Teq, February 22, 2017 Summary Basis for Regulatory Action - RotaTeq, Patient Information - RotaTeq, Package Insert - RotaTeq, Supporting Documents older than three years - RotaTeq |
| FDA page updated | Aug 17, 2020 |
| 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: