OTC User Fee Program

General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

OMB: 0910-0340

IC ID: 244708

Documents and Forms

Document Name Document Type
Form FDA 5009 OTC User Fee Program Form
FDA 5009 OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET Draft OTC Coversheet Form FDA 5009 Dec 2020.docx Form