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: Hepatitis B Vaccine (Recombinant)
Tradename: Recombivax
Manufacturer: Merck & Co, Inc, West Point, PA, License #0002
Manufacturing Change: Preservative-free pediatric / adolescent product
Approval Date: 8/27/99
Type of submission: Product license application supplement

horizontal rule

Approval Letter - (Text), (PDF)

 

 
horizontal rule