ANDA 202182, held by Hikma Farmaceutica. Zoledronic Acid.
As of Nov 15, 2026, ANDA 202182 (Zoledronic Acid), held by Hikma Farmaceutica, was first approved by FDA on Jun 3, 2013, with 4 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 nontumor-related hypercalcemia. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 4MG BASE/5ML · injectable;intravenous | Zoledronic Acid | Rx |
| Oct 20, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 20, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 20, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 19, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 3, 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
