
 
  


Telecon PNR - August 12, 2009 - Gammaplex




 
RECORD OF TELEPHONE CONVERSATION

 

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

Product:

Immune Globulin Intravenous (Human), 5% Liquid

Applicant:                                                                       
 

Bio Product Laboratory          

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

Telephone Number:    

Communication Categorie(s):

Advice

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.
 

   