2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC674
Submitter : Mr. John Foley Date & Time: 10/12/2005 06:10:28
Organization : Mr. John Foley
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Product should not be sold over the counter.