ANDA 201801, held by Avet Lifesciences. Zoledronic Acid.
As of Nov 15, 2026, ANDA 201801 (Zoledronic Acid), held by Avet Lifesciences, was first approved by FDA on Mar 29, 2013, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 5MG BASE/100ML · injectable;intravenous | Zoledronic Acid | Discontinued |
| Jul 18, 2016 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 24, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 29, 2013 | Original application | 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
