Prevents postmenopausal osteoporosis ( 1.1, 1.2 ). ANDA 209125, held by Eugia Pharma. Zoledronic Acid.
As of Nov 15, 2026, ANDA 209125 (Zoledronic Acid), held by Eugia Pharma, was first approved by FDA on Dec 8, 2017, with 3 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 8, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 5MG BASE/100ML · injectable;intravenous | Zoledronic Acid | Discontinued |
| May 20, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 13, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 7, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 8, 2017 | 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
