Zoledronic Acid

ANDA 202472, held by Actavis Inc. Zoledronic Acid.

As of Nov 15, 2026, ANDA 202472 (Zoledronic Acid), held by Actavis Inc, 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

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	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 4, 2021	Supplement 5Labeling · Standard review	Approved	None posted
May 4, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Nov 18, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Oct 21, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Oct 21, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Mar 4, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202472
Drugs@FDA: Overview at FDA
Company: Actavis

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