Availability of Drug Products; Pharmaceutical Equivalence

Section 790 Section 790.200  Availability of Drug Products; Pharmaceutical Equivalence Drug products included must be available from more than one approved manufacturing source unless otherwise noted.  Drug products listed must be pharmaceutically equivalent to at least one other drug product under the same entity listing.  Drug products are pharmaceutically equivalent if they contain the same active ingredients, are identical in dosage form and route of administration, are formulated to meet the same or comparable standards and vary in labeled dosage strength by no more than 1%.