Zoledronic Acid

ANDA 200918, held by Epic Pharma LLC. Zoledronic Acid.

As of Nov 14, 2026, ANDA 200918 (Zoledronic Acid), held by Epic Pharma LLC, was first approved by FDA on Aug 21, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 21, 2014
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
Aug 21, 2014	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Dec 14, 2017	Supplement 1Labeling · Standard review	Approved	None posted
Aug 21, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 200918
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