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Prevents postmenopausal osteoporosis (1.1, 1.2). ANDA 204217, held by Gland. Zoledronic Acid.
As of Nov 14, 2026, ANDA 204217 (Zoledronic Acid), held by Gland, was first approved by FDA on Aug 18, 2016, with 2 approved supplements and 0 published complete response letters.
First approved: Aug 18, 2016
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Zoledronic acid injection is a bisphosphonate indicated for:
Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2)
Treatment to increase bone mass in men with osteoporosis
Treatment and prevention of glucocorticoid-induced osteoporosis
Treatment of Paget’s disease of bone in men and women Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use 1.1 Treatment of Osteoporosis in Postmenopausal Women Zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women.
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
