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

Telecon PNR - August 12, 2009 - Gammaplex



Submission Type: Original Application   Submission ID:  125329/0    Office: OBRR  


Immune Globulin Intravenous (Human), 5% Liquid


Bio Product Laboratory          

Telecon Date/Time:  12-AUG-2009 12:00 AM              Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):


Author:  HON SUM KO

Telecon Summary:

Need for new proprietary name

FDA Participants:   Hon-Sum Ko

Non-FDA Participants:    Howard Smith

Trans-BLA Group: No  

Related STNs:  None

Related PMCs:  None

Telecon Body:

BPL was contacted and informed that a new proprietary name was needed. They were asked to submit a new name in one week.

Page Last Updated: 02/17/2017
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