Zoledronic Acid

ANDA 202837, held by Hospira Inc. Zoledronic Acid.

As of Nov 15, 2026, ANDA 202837 (Zoledronic Acid), held by Hospira Inc, was first approved by FDA on Apr 5, 2013, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 5, 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
Apr 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	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Nov 1, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Nov 1, 2022	Supplement 7Labeling · Standard review	Approved	None posted
Mar 1, 2017	Supplement 4Labeling · Standard review	Approved	None posted
Sep 22, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Nov 20, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Apr 5, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202837
Drugs@FDA: Overview at FDA
Company: Hospira

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