Caricamenti by Shilpa Kotian

The ANDA Workshop Filing Process_May 2007

Formatting of Bioequivalence Summary Tables

ANDA Filing Checklist_Dec 2011

Q1E_Evaluation for Stability Data

Generic Modified Release Drug Products

Formating of Bio Equivalence Summary Tables

Quality by Design for ANDAs_MR Tablets

FDA interpretation of 505(b)(2) NDA

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