ANDA 201783, held by Avet Lifesciences. Zoledronic Acid.
As of Nov 15, 2026, ANDA 201783 (Zoledronic Acid), held by Avet Lifesciences, was first approved by FDA on Mar 12, 2013, with 6 approved supplements and 0 published complete response letters.
Zoledronic acid injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy. Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Limitations of Use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 4MG BASE/5ML · injectable;intravenous | Zoledronic Acid | Rx |
| Jun 6, 2024 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jul 14, 2016 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 9, 2015 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 31, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 31, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 31, 2015 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 12, 2013 | 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
