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Issue A Bioequivalence Guidance for Mesalamine Delayed-Release Tablets & Refrain from Approving any Abbreviated New Drug Application (ANDA) Referencing Asacol® and/or Asacol® HD Unless the Proposed Generic Product Is Shown to Be Bioequivalente Based on Appropriate Data-CLOSED

Abstract: Status: CLOSED (Reopened, September 17, 2010 & PRC received)-Closed per letter of 8/20/2010
Type: Non-Rule Making
Docket Item Code P
Center CDER

Primary Documents (3)