ANDA 210174, held by Amneal. Zoledronic Acid.
As of Nov 14, 2026, ANDA 210174 (Zoledronic Acid), held by Amneal, was first approved by FDA on Oct 27, 2017, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 4MG BASE/100ML · injectable;intravenous | Zoledronic Acid | Rx |
| Feb 21, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 27, 2017 | Original application | Approved | None posted |
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
