Cymbalta

NDA 21733, held by Lilly. Duloxetine Hydrochloride.

As of Nov 14, 2026, NDA 21733 (Cymbalta), held by Lilly, was first approved by FDA on Sep 3, 2004, with 0 approved supplements and 0 published complete response letters.

• First approved: Sep 3, 2004
• Review: Priority
• 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