ANDA 204344, held by Dr Reddys. Zoledronic Acid.
As of Nov 15, 2026, ANDA 204344 (Zoledronic Acid), held by Dr Reddys, was first approved by FDA on Nov 19, 2018, with 0 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.. Limitation 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 |
|---|---|---|---|
| Nov 19, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 4MG BASE/100ML · injectable;intravenous | Zoledronic Acid | Discontinued |
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
