FDA — authorised 28 February 1983
- Application: NDA018226
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: BUMEX
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Bumex in United States
FDA authorised Bumex on 28 February 1983
Marketing authorisations
FDA — authorised 28 February 1983
- Application: NDA018225
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: BUMEX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1994
- Application: ANDA074332
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUMETANIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 January 1995
- Application: ANDA074441
- Marketing authorisation holder: SAGENT
- Local brand name: BUMETANIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 April 1995
- Application: ANDA074225
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 1996
- Application: ANDA074700
- Marketing authorisation holder: SANDOZ
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 November 1997
- Application: ANDA074613
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: BUMETANIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 2008
- Application: ANDA079196
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: BUMETANIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 October 2017
- Application: ANDA209724
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 2018
- Application: ANDA202900
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 December 2019
- Application: ANDA212019
- Marketing authorisation holder: RISING
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 May 2022
- Application: ANDA216434
- Marketing authorisation holder: GLAND
- Local brand name: BUMETANIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 August 2022
- Application: ANDA215364
- Marketing authorisation holder: MSN
- Local brand name: BUMETANIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 September 2024
- Application: ANDA217153
- Marketing authorisation holder: LUPIN
- Local brand name: BUMETANIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 September 2024
- Application: ANDA212931
- Marketing authorisation holder: APPCO
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 2024
- Application: ANDA219116
- Marketing authorisation holder: QILU PHARM HAINAN
- Status: approved
FDA — authorised 27 December 2024
- Application: ANDA213942
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2025
- Application: ANDA218746
- Marketing authorisation holder: ASPIRO
- Local brand name: BUMETANIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 April 2025
- Application: ANDA219291
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 2025
- Application: ANDA212470
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 September 2025
- Application: NDA219500
- Marketing authorisation holder: CORSTASIS THERAP
- Local brand name: ENBUMYST
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 5 February 2026
- Application: ANDA215362
- Marketing authorisation holder: MSN
- Local brand name: BUMETANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2026
- Application: ANDA220427
- Marketing authorisation holder: ANTHEA PHARMA
- Local brand name: BUMETANIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Bumex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Bumex approved in United States?
Yes. FDA authorised it on 28 February 1983; FDA authorised it on 28 February 1983; FDA authorised it on 31 October 1994.
Who is the marketing authorisation holder for Bumex in United States?
VALIDUS PHARMS holds the US marketing authorisation.