Treats Paget’s disease of bone. ANDA 91363, held by Dr Reddys Labs Ltd. Zoledronic Acid.
As of Nov 15, 2026, ANDA 91363 (Zoledronic Acid), held by Dr Reddys Labs Ltd, was first approved by FDA on Mar 29, 2013, with 4 approved supplements and 0 published complete response letters.
Zoledronic acid injection is a bisphosphonate indicated for: Treatment of Paget’s disease of bone in men and women 1.5 Paget's Disease of Bone Zoledronic acid injection is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 5MG BASE/100ML · injectable;intravenous | Zoledronic Acid | Rx |
| Mar 7, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 18, 2017 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 2, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 9, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 29, 2013 | Original application | Approved |
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
