ANDA 202571, held by Chartwell Rx. Zoledronic Acid.
As of Nov 15, 2026, ANDA 202571 (Zoledronic Acid), held by Chartwell Rx, was first approved by FDA on May 7, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 4MG BASE/5ML ยท injectable;intravenous | Zoledronic Acid | Rx |
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
