Zoledronic Acid

ANDA 202548, held by Epic Pharma LLC. Zoledronic Acid.

As of Nov 14, 2026, ANDA 202548 (Zoledronic Acid), held by Epic Pharma LLC, was first approved by FDA on May 22, 2014, with 4 approved supplements and 0 published complete response letters.

First approved: May 22, 2014
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 22, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zoledronic AcidEQ 4MG BASE/5ML · injectable;intravenous	Zoledronic Acid	Rx

All 5 submissions, including labeling and manufacturing supplements


Jun 14, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jun 14, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Jun 14, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jun 14, 2024	Supplement 1Labeling · Standard review	Approved	None posted
May 22, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202548
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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