
Acknowledgement Letter - Intersol


 

 
Fenwal, Inc.
 Attention: Ms. Cheryl Chamberlain Roscher
 Three Corporate Drive
 Lake Zurich, IL 60047

Dear Ms. Chamberlain Roscher:

We have received your new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug and Cosmetic Act for the following:

 Submission Tracking Number: BN080041

Name of Drug Product:         InterSol solution

Date of Application: 3          1-JUL-08

Date of Receipt:                 04-AUG-08

Action Due Date:                04-JUN-09

Unless we notify you within 60 days of the receipt date that the application is not sufficiently complete to permit a substantive review, this application will be filed under section 505(b) of the Act on the date sixty days from the date of receipt of application in accordance with 21 CFR 314.101(a).

Please cite the NDA number listed above at the top of the first page of any communications concerning this application.

If you have any questions, please contact the Regulatory Project Manager, Heather Erdman, at (301) 827-6182.

Sincerely yours,

Heather Erdman, RAC
 Regulatory Project Manager
 Division of Blood Applications
 Office of Blood Research and Review
 Center for Biologics
 Evaluation and Research
