Zoledronic Acid

ANDA 202746, held by Sun Pharma Global. Zoledronic Acid.

As of Nov 14, 2026, ANDA 202746 (Zoledronic Acid), held by Sun Pharma Global, was first approved by FDA on Mar 4, 2013, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 4, 2013
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 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 2 submissions, including labeling and manufacturing supplements


Sep 11, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Mar 4, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202746
Drugs@FDA: Overview at FDA
Company: Sun Pharma Global Inc.

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