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 : EC1053
Submitter : Mr. Zachary Lazarus Date & Time: 10/27/2005 10:10:37
Organization : Mr. Zachary Lazarus
Category : Drug Association
Issue Areas/Comments
OTC EC drugs must be made fully accessible as soon as possible. The delays that have occurred regarding the accessibility of these drugs are unacceptable.