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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, August 16, 2010 - Adenovirus

Submission Type: BLA Submission ID: 125296/0 Office: OVRR

Product:
Adenovirus Vaccine Live Oral Type 4 and Type 7

Applicant:
Teva Women's Health, Inc.

Telecon Date/Time: 16-Aug-2010 11:36 AM Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
1. Other - UNII Codes

Author: LAWRENCE CALLAHAN

Telecon Summary:
UNII Code Request

FDA Participants: None

Non-FDA Participants: None

Trans-BLA Group: No


Related STNs: None

Related PMCs: None

Telecon Body:


From: Callahan, Lawrence
Sent: Monday, August 16, 2010 11:36 AM
To: Gemignani, Helen S; Switzer, Frank; Peden, Keith
Cc: Hithe, Darlene; CBER SRS; Levis, Robin
Subject: RE: UNII Code Request - STN 125296/0 - Adenovirus Vaccine


We have created the following UNII for the adenovirus antigens

HUMAN ADENOVIRUS SEROTYPE 4 STRAIN CL-68578 UNII FKD3DUK39I

HUMAN ADENOVIRUS SEROTYPE 7 STRAIN 55142
UNII TM54L796SN

Larry Callahan, Ph. D.
Food and Drug Administration
Building 32, 4154
Phone 301-796-8489
email: lawrence.callahan@fda.hhs.gov
Mailing Address
Building 32, room 4103
10903 New Hampshire Ave.
Silver Spring, MD 20993