Prevents postmenopausal osteoporosis ( 1.1, 1.2 ). ANDA 209578, held by Gland. Zoledronic Acid.
As of Nov 14, 2026, ANDA 209578 (Zoledronic Acid), held by Gland, was first approved by FDA on Aug 8, 2019, with 1 approved supplement 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 |
|---|---|---|---|
| Aug 8, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 5MG BASE/100ML · injectable;intravenous | Zoledronic Acid | Rx |
| Nov 8, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 8, 2019 | 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
