Zoledronic Acid

Prevents postmenopausal osteoporosis ( 1.1, 1.2 ). ANDA 202828, held by Inforlife. Zoledronic Acid.

As of Nov 15, 2026, ANDA 202828 (Zoledronic Acid), held by Inforlife, was first approved by FDA on Sep 23, 2013, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 23, 2013
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Sep 23, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zoledronic AcidEQ 5MG BASE/100ML · injectable;intravenous	Zoledronic Acid	Rx

All 9 submissions, including labeling and manufacturing supplements


Aug 15, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Nov 2, 2022	Supplement 13Labeling · Standard review	Approved	None posted
Nov 2, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Nov 2, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Nov 2, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Aug 21, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Apr 26, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Apr 26, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Sep 23, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202828
Drugs@FDA: Overview at FDA
Company: Inforlife

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