Zoledronic Acid

ANDA 202650, held by Mylan Labs Ltd. Zoledronic Acid.

As of Nov 14, 2026, ANDA 202650 (Zoledronic Acid), held by Mylan Labs Ltd, was first approved by FDA on Mar 4, 2013, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 4, 2013
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 4, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zoledronic AcidEQ 4MG BASE/5ML · injectable;intravenous	Zoledronic Acid	Rx

All 6 submissions, including labeling and manufacturing supplements


Oct 19, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Nov 30, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Oct 20, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Mar 12, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Mar 12, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Mar 4, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202650
Drugs@FDA: Overview at FDA
Company: Mylan Laboratories

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