Zoledronic Acid

ANDA 90621, held by Hospira. Zoledronic Acid.

As of Nov 14, 2026, ANDA 90621 (Zoledronic Acid), held by Hospira, was first approved by FDA on Mar 19, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 19, 2015
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 19, 2015	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 3 submissions, including labeling and manufacturing supplements


Mar 21, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Mar 21, 2017	Supplement 4Labeling · Standard review	Approved	None posted
Mar 19, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 90621
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