NDA 204016, held by Hospira. Zoledronic Acid.
As of Nov 13, 2026, NDA 204016 (Zoledronic Acid), held by Hospira, was first approved by FDA on Dec 28, 2015, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 28, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) · solution;intravenous | Zoledronic Acid | Discontinued |
| Dec 19, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Apr 29, 2016 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 28, 2015 | Original applicationNew formulation or manufacturer · Standard 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
