Cymbalta

NDA 22148, held by Lilly. Duloxetine Hydrochloride.

As of Nov 13, 2026, NDA 22148 (Cymbalta), held by Lilly, was first approved by FDA on Jun 13, 2008, with 0 approved supplements and 0 published complete response letters.

• First approved: Jun 13, 2008
• Review: Standard
• Supplements approved: 0
• 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