Onsolis

NDA 22266, held by Adalvo. Fentanyl Citrate.

As of Nov 13, 2026, NDA 22266 (Onsolis), held by Adalvo, was first approved by FDA on Jul 16, 2009, with 14 approved supplements and 0 published complete response letters.

• First approved: Jul 16, 2009
• Review: Standard
• Supplements approved: 14
• 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