Zometa

NDA 21223, held by Novartis. Zoledronic Acid.

As of Nov 14, 2026, NDA 21223 (Zometa), held by Novartis, was first approved by FDA on Aug 20, 2001, with 28 approved supplements and 0 published complete response letters.

First approved: Aug 20, 2001
Review: Priority
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below


Mar 20, 2008	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 20, 2001	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Written Request

Products

3 strengths and forms


ZometaEQ 4MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intravenous	Zoledronic Acid	DiscontinuedReference drug
ZometaEQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intravenous	Zoledronic Acid	DiscontinuedReference drug
ZometaEQ 4MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intravenous	Zoledronic Acid	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements


Dec 14, 2018	Supplement 41Labeling · Standard review	Approved	Label Letter
Jan 26, 2017	Supplement 38Manufacturing · Standard review	Approved	None posted
Dec 28, 2016	Supplement 35Labeling · Standard review	Approved	Label Letter
Nov 15, 2016	Supplement 36Manufacturing · Standard review	Approved	None posted
Apr 22, 2016	Supplement 33Manufacturing · Priority review	Approved	None posted
Mar 29, 2016	Supplement 34Labeling · Standard review	Approved	Letter Label
Jun 9, 2015	Supplement 32Labeling · Standard review	Approved	Label Letter
Jan 5, 2015	Supplement 31Labeling · Standard review	Approved	Label Letter
Jun 17, 2014	Supplement 30Manufacturing · Priority review	Approved	None posted
Apr 7, 2014	Supplement 28Labeling · Standard review	Approved	Label Letter
Sep 27, 2013	Supplement 27Labeling · Standard review	Approved	Letter Label
Mar 6, 2013	Supplement 25Manufacturing · Priority review	Approved	None posted
Nov 9, 2012	Supplement 23Labeling · Standard review	Approved	Label Letter
Mar 14, 2012	Supplement 22Labeling	Approved	Letter Label
Nov 9, 2009	Supplement 18Labeling · Standard review	Approved	Letter Label
Mar 20, 2008	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 2, 2007	Supplement 15Labeling · Standard review	Approved	Letter
Nov 2, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
May 25, 2006	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 11, 2005	Supplement 11Labeling · Standard review	Approved	Label Letter
Jan 31, 2005	Supplement 10Labeling · Standard review	Approved	Label Letter
Jan 31, 2005	Supplement 9Labeling · Standard review	Approved	Letter Label
Mar 24, 2004	Supplement 8Labeling · Standard review	Approved	Label Letter
Feb 27, 2004	Supplement 6Labeling · Standard review	Approved	Label Letter
Mar 7, 2003	Supplement 4Manufacturing · Priority review	Approved	Review Letter Label
May 13, 2002	Supplement 2Manufacturing · Priority review	Approved	None posted
Feb 22, 2002	Supplement 3Labeling · Standard review	Approved	Letter Label Review
Feb 12, 2002	Supplement 1Manufacturing · Priority review	Approved	None posted
Aug 20, 2001	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Written Request

Identifiers

Application: NDA 21223
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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