2006P-0403 Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15>20manufactured by Hospira under NDA 17-957
FDA Comment Number : EC1
Submitter : Mr. Dave Lowe Date & Time: 10/10/2006 12:10:38
Organization : Mr. Dave Lowe
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I oppose the petition. An Electronic Orange Book search for Novamine is included for regulatory action.
2006P-0403-EC1-Attach-1.PDF