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 : EC1139
Submitter : Ms. Katherine Lory Date & Time: 10/27/2005 02:10:45
Organization : Ms. Katherine Lory
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
The drug should be available without a prescription.