Note
Executive Summary
This table may be divided, and additional information on a particular entry may appear on more than one screen. (FOOTNOTE) n1 These products have been approved subject to the demonstration of effectiveness of the subject active ingredients and dosage form pursuant to FDA Single-entity Coronary Vasodilator regulation (43 FR 41262). n2 establishment license issued; n3 product license issued; n4 determination of substantially equivalent for Premarket Notification [510(k)].(END FOOT)