Zoledronic Acid

ANDA 204367, held by Apotex. Zoledronic Acid.

As of Nov 15, 2026, ANDA 204367 (Zoledronic Acid), held by Apotex, was first approved by FDA on Dec 24, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 24, 2015
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
Dec 24, 2015	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Mar 7, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Oct 25, 2017	Supplement 1Labeling · Standard review	Approved	None posted
Oct 25, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Dec 24, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204367
Drugs@FDA: Overview at FDA
Company: Apotex

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