Requests that the FDA Require ANDA 220582 to be supported with in vivo bioequivalence data from a study involving the product for which approval is being sought under the ANDA; Require ANDA 220582 and other ANDAs that reference BELBUCA to include data and information justifying the entire pH range in the product specifications to ensure that intentional changes to pH compared to BELBUCA. | Federal Regulations · Congress.wiki