Femtrace

NDA 21633, held by Apil. Estradiol Acetate.

As of Nov 14, 2026, NDA 21633 (Femtrace), held by Apil, was first approved by FDA on Aug 20, 2004, with 2 approved supplements and 0 published complete response letters.

• First approved: Aug 20, 2004
• Review: Standard
• Supplements approved: 2
• Complete response letters: 0

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters