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: Human T-Lymphotropic Virus Type I p21E Antigen
Tradename: none
Manufacturer: Organon Teknika, B.V., Boxtel, The Netherlands, License #1103
Indication for Use: For further manufacture to Human T-Lymphotropic Virus Types I&II under a shared manufacturing arrangement with Organon Teknika Corp
Approval Date: 1/17/98
Type of submission: Product license application

horizontal rule

Approval Letter - (PDF), (Text)

 

 
horizontal rule