FDA — authorised 27 November 1973
- Marketing authorisation holder: UCB INC
- Status: approved
🇺🇸 Zaroxolyn in United States
FDA authorised Zaroxolyn on 27 November 1973
Marketing authorisations
FDA — authorised 27 November 1973
- Application: NDA017386
- Marketing authorisation holder: I3 PHARMS
- Local brand name: ZAROXOLYN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 1981
- Application: NDA018535
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: DIULO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 1987
- Application: NDA019532
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: MYKROX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 2003
- Application: ANDA076732
- Marketing authorisation holder: SANDOZ
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 2003
- Application: ANDA076466
- Marketing authorisation holder: SANDOZ
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 December 2003
- Application: ANDA075543
- Marketing authorisation holder: ANI PHARMS
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 2004
- Application: ANDA076482
- Marketing authorisation holder: ROXANE
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 2004
- Application: ANDA076891
- Marketing authorisation holder: WATSON LABS
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 2004
- Application: ANDA076698
- Marketing authorisation holder: MYLAN
- Indication: Labeling
- Status: approved
FDA — authorised 2 December 2020
- Application: ANDA213251
- Marketing authorisation holder: ALEMBIC
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2021
- Application: ANDA214799
- Marketing authorisation holder: UNICHEM
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2021
- Application: ANDA213827
- Marketing authorisation holder: INNOGENIX
- Status: approved
FDA — authorised 20 August 2021
- Application: ANDA215184
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 October 2022
- Application: ANDA215616
- Marketing authorisation holder: RENATA
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2022
- Application: ANDA216216
- Marketing authorisation holder: NE RX PHARMA
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 November 2024
- Application: ANDA217563
- Marketing authorisation holder: MICRO LABS
- Local brand name: METOLAZONE
- Indication: TABLET — ORAL
- Status: approved
Zaroxolyn in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Zaroxolyn approved in United States?
Yes. FDA authorised it on 27 November 1973; FDA authorised it on 27 November 1973; FDA authorised it on 24 February 1981.
Who is the marketing authorisation holder for Zaroxolyn in United States?
UCB INC holds the US marketing authorisation.