Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs

This guidance document is intended to provide sponsors with an outline of the chemistry and manufacturing, clinical, and human safety requirements for the filing of the following submission types with the Veterinary Drugs Directorate (VDD): Abbreviated New Drug Submission (ANDS); Changes to ANDS - Supplemental Abbreviated New Drug Submission (SANDS) and Notifiable Change (NC).