shilpa-kotian documents

Generic Modified Release Drug Products
Documents Generic Modified Release Drug Products
Q1E_Evaluation for Stability Data
Documents Q1E_Evaluation for Stability Data
Formatting of Bioequivalence Summary Tables
Documents Formatting of Bioequivalence Summary Tables
The ANDA Workshop Filing Process_May 2007
Documents The ANDA Workshop Filing Process_May 2007
Quality by Design for ANDAs_MR Tablets
Documents Quality by Design for ANDAs_MR Tablets
FDA interpretation of 505(b)(2) NDA
Documents FDA interpretation of 505(b)(2) NDA
ANDA Filing Checklist_Dec 2011
Documents ANDA Filing Checklist_Dec 2011
Approval and Manufacture of New Drug (Domestic and Export)_08.11.11
Documents Approval and Manufacture of New Drug (Domestic and Export)_08.11.11