ANDA 91186, held by Dr Reddys Labs Ltd. Zoledronic Acid.
As of Nov 14, 2026, ANDA 91186 (Zoledronic Acid), held by Dr Reddys Labs Ltd, was first approved by FDA on Mar 4, 2013, with 7 approved supplements and 0 published complete response letters.
Zoledronic acid injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy. Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Limitations of Use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic AcidEQ 4MG BASE/5ML · injectable;intravenous | Zoledronic Acid | Rx |
| Feb 21, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Feb 21, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jul 11, 2016 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 21, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 6, 2015 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 6, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 6, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 4, 2013 | 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
