Reclast

NDA 22080, held by Sandoz. Zoledronic Acid.

As of Nov 14, 2026, NDA 22080 (Reclast), held by Sandoz, was first approved by FDA on Aug 17, 2007, with 0 approved supplements and 0 published complete response letters.

• First approved: Aug 17, 2007
• 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