Generic Modified Release Drug Products

Q1E_Evaluation for Stability Data

Formatting of Bioequivalence Summary Tables

The ANDA Workshop Filing Process_May 2007

Quality by Design for ANDAs_MR Tablets

FDA interpretation of 505(b)(2) NDA

ANDA Filing Checklist_Dec 2011

Approval and Manufacture of New Drug (Domestic and Export)_08.11.11