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:||31-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.
Heather Erdman, RAC
Regulatory Project Manager
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research