FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas
CBER links
horizontal rule

Product Approval Information - Licensing Action

horizontal rule

Proper name: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Tradename: Prevnar
Manufacturer: Lederle Laboratories Division American Cyanamid Company, W. Henrietta, NY, License #0017
Indication for Use: Immunization of infants and toddlers against otitis media caused by vaccine serotypes
Approval Date: 10/1/2002
Type of submission: Biologics license application supplement

horizontal rule

Approval Letter - (Text)

Label - (PDF)

 

Updated October 22, 2002
 
horizontal rule

CBER Home Page | CBER A-Z Index | CBER Search | Contact CBER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA / Center for Biologics Evaluation and Research