Zoledronic Acid

ANDA 202163, held by Chartwell Rx. Zoledronic Acid.

As of Nov 14, 2026, ANDA 202163 (Zoledronic Acid), held by Chartwell Rx, was first approved by FDA on Aug 5, 2013, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 5, 2013
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 5, 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 4 submissions, including labeling and manufacturing supplements


Jan 11, 2017	Supplement 4Labeling · Standard review	Approved	None posted
Jul 2, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Jul 2, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Aug 5, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202163
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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