NDA 21386, held by Novartis. Zoledronic Acid.
As of Nov 14, 2026, NDA 21386 (Zometa), held by Novartis, was first approved by FDA on Feb 22, 2002, with 2 approved supplements and 0 published complete response letters.
| Feb 27, 2004 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Feb 22, 2002 | Original applicationTYPE 6 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZometaEQ 4MG BASE/VIAL · injectable; iv (infusion) | Zoledronic Acid | Rx |
| Feb 4, 2011 | Supplement 4Labeling | Approved | |
| Feb 27, 2004 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Feb 22, 2002 | Original applicationTYPE 6 · Priority review | Approved |
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
