ANDA 91516, held by Fresenius Kabi USA. Zoledronic Acid.
As of Nov 15, 2026, ANDA 91516 (Zoledronic Acid), held by Fresenius Kabi USA, was first approved by FDA on Apr 23, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 23, 2015 | Original application | Approved |
| 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
