ANDA 205279, held by Accord Hlthcare. Zoledronic Acid.
As of Nov 14, 2026, ANDA 205279 (Zoledronic Acid), held by Accord Hlthcare, was first approved by FDA on Nov 28, 2016, with 3 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 |
|---|---|---|---|
| Nov 28, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 4MG BASE/5ML · injectable;intravenous | Zoledronic Acid | Rx |
| Jul 30, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 21, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 21, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 28, 2016 | 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
