FDA — authorised 20 August 2001
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Zometa in United States
FDA authorised Zometa on 20 August 2001
Marketing authorisations
FDA — authorised 4 March 2013
- Application: ANDA091170
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 March 2013
- Application: ANDA202472
- Marketing authorisation holder: ACTAVIS INC
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 March 2013
- Application: ANDA091186
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 12 March 2013
- Application: ANDA201783
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 29 March 2013
- Application: ANDA201801
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 5 April 2013
- Application: ANDA202837
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 May 2013
- Application: ANDA202571
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 3 June 2013
- Application: ANDA202182
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 2 August 2013
- Application: NDA203231
- Marketing authorisation holder: INFORLIFE
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 5 August 2013
- Application: ANDA202163
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 5 August 2013
- Application: ANDA202930
- Marketing authorisation holder: GLAND
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 September 2013
- Application: ANDA202828
- Marketing authorisation holder: INFORLIFE
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 22 May 2014
- Application: ANDA202548
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 21 August 2014
- Application: ANDA200918
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 September 2014
- Application: ANDA202923
- Marketing authorisation holder: USV
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 24 November 2014
- Application: ANDA091493
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 April 2015
- Application: ANDA091516
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 24 December 2015
- Application: ANDA204367
- Marketing authorisation holder: APOTEX
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 December 2015
- Application: NDA204016
- Marketing authorisation holder: HOSPIRA
- Local brand name: ZOLEDRONIC ACID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 28 November 2016
- Application: ANDA205279
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 October 2017
- Application: ANDA205254
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 November 2018
- Application: ANDA204344
- Marketing authorisation holder: DR REDDYS
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 5 February 2026
- Application: ANDA219984
- Marketing authorisation holder: GLAND
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
The FDA approved Zometa (Zoledronic Acid) for intravenous use on 2026-02-05. The marketing authorisation holder is GLAND. The application was submitted under the standard expedited pathway. Zometa is an injectable drug used for a specific indication, as stated in the FDA approval.
FDA
- Application: ANDA078533
- Marketing authorisation holder: APOTEX INC
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — IV (INFUSION)
- Status: approved
FDA
- Application: ANDA091187
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA078576
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — IV (INFUSION)
- Status: approved
FDA
- Application: ANDA203344
- Marketing authorisation holder: PFIZER INC
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA204051
- Marketing authorisation holder: SUN PHARMA GLOBAL
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA078580
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: ZOLEDRONIC ACID
- Indication: INJECTABLE — IV (INFUSION)
- Status: approved
Zometa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Zometa approved in United States?
Yes. FDA authorised it on 20 August 2001; FDA authorised it on 4 March 2013; FDA authorised it on 4 March 2013.
Who is the marketing authorisation holder for Zometa in United States?
NOVARTIS holds the US marketing authorisation.