New Animal Drug Application Submissions

New Animal Drug Applications; Abbreviated New Animal Drug Applications; and Veterinary Master Files

OMB: 0910-0032

IC ID: 5688

Documents and Forms

Document Name Document Type
Form 356V New Animal Drug Application Submissions Form and Instruction
356V Application for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval) FDA-356v.pdf Form and Instruction
CVM-GFI--152-Evaluating-the-Safety-of-Antimicrobial-New-Animal-Drugs-with-Regard-to-Their-Microbiological-Effects-on-Bacteria-of-Human-Health-Concern.pdf Other-Agency Guidance