This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.
Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License Number | Approval Date |
---|---|---|---|---|
CAPVAXIVE Pneumococcal 21-valent Conjugate Vaccine | Indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older. | 125814/0 | Merck Sharp & Dohme LLC P.O. Box 1000 UG2D-68 North Wales, PA 19454-2505 |