1998 Biological New Drug Application (NDA) Approvals

This list reflects information regarding the applications as of the approval date; it is not updated with regard to applicant or application status changes.


Tradename/
Established Name
Indication for Use Applicant Approval Date
Hetastarch 6% Hetastarch in 0.9% NaC1 in EXCEL Containers McGaw, Inc
2525 McGaw Ave
P.O. Box 19791
Irvine, CA 92623-9791
10/21/1998
Hetastarch 6% Hetastarch in 0.9% NaCl in 500 mL Plastic Bags Gensia Laboratories, Inc
19 Hughes
Irvine, CA 92718-1902
11/12/1998
 
Updated: October 3, 2003