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As of Nov 14, 2026, ANDA 205749 (Zoledronic, Zoledronic Acid), held by Gland, was first approved by FDA on Jun 29, 2018, with 1 approved supplement and 0 published complete response letters.
First approved: Jun 29, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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 non-tumor-related hypercalcemia. 1.
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
