Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

1997 Biological License Application Supplement Approvals

This list reflects information regarding the supplements as of the approval date; it is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.

Proper Name
Indication for Use Manufacturer/
License No.
Approval Date
Venoglobulin-I or
Immune Globulin Intravenous (Human)
New Indication:
Treatment of Kawasaki Disease in conjunction with high dose aspirin
(100 mg/kg/day)
Alpha Therapeutic Corp
5555 Valley Blvd
Los Angeles, CA 90032
License 0744
Hepatitis A Vaccine Inactivated
New Indication:
Prevention of Hepatitis A in patients with chronic liver disease
SmithKline Beecham
89, rue de l'Institut
1330 Rixensart
License 1090

Page Last Updated: 04/04/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English