Zoledronic Acid

ANDA 91170, held by Breckenridge. Zoledronic Acid.

As of Nov 14, 2026, ANDA 91170 (Zoledronic Acid), held by Breckenridge, was first approved by FDA on Mar 4, 2013, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 4, 2013
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 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	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Feb 21, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Feb 21, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Mar 24, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Mar 25, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Mar 25, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Mar 31, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Mar 4, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 91170
Drugs@FDA: Overview at FDA
Company: Breckenridge Pharmaceutical

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