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 : EC1073
Submitter : Dr. Randi Protter Date & Time: 10/27/2005 10:10:55
Organization : WHCC
Category : Health Professional
Issue Areas/Comments
EC is safe and effective with minimal side effects. It is available OTC in other countries and has not been proven to increase morbidity or mortality.