Prevents postmenopausal osteoporosis ( 1.1, 1.2 ). ANDA 213371, held by Meitheal. Zoledronic Acid.
As of Nov 15, 2026, ANDA 213371 (Zoledronic Acid), held by Meitheal, was first approved by FDA on Jun 5, 2023, with 0 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 |
|---|---|---|---|
| Jun 5, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 5MG BASE/100ML · injectable;intravenous | Zoledronic Acid | Rx |
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
