Zoledronic Acid

ANDA 91493, held by Sagent Pharms Inc. Zoledronic Acid.

As of Nov 14, 2026, ANDA 91493 (Zoledronic Acid), held by Sagent Pharms Inc, was first approved by FDA on Nov 24, 2014, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 24, 2014
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 24, 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 7 submissions, including labeling and manufacturing supplements


Dec 21, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Dec 21, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Dec 21, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Dec 21, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Sep 3, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Sep 3, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Nov 24, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 91493
Drugs@FDA: Overview at FDA
Company: Sagent Pharmaceuticals

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