FDA — authorised 1 July 1966
- Application: NDA016273
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: LASIX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lasix in United States
FDA authorised Lasix on 1 July 1966
Marketing authorisations
FDA — authorised 20 March 1968
- Application: NDA016363
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: LASIX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 March 1977
- Application: NDA017688
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: LASIX
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 January 1979
- Application: NDA018025
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 May 1981
- Application: NDA018267
- Marketing authorisation holder: HIKMA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 1981
- Application: NDA018487
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 1981
- Application: NDA018569
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 1982
- Application: NDA018369
- Marketing authorisation holder: WATSON LABS
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 May 1982
- Application: NDA018667
- Marketing authorisation holder: HOSPIRA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Hospira's Lasix, a furosemide-based medication, has been granted marketing authorisation by the FDA in the United States. This authorisation was granted on 01 October 2024, following a standard expedited pathway application under NDA018667. The approved indication for Lasix is as labelled, although the specific details of the labelled indication are not reported in the provided information.
FDA — authorised 27 July 1982
- Application: NDA018415
- Marketing authorisation holder: ESJAY PHARMA
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 1983
- Application: NDA018413
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 1983
- Application: NDA018579
- Marketing authorisation holder: AM REGENT
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 1984
- Application: NDA018753
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 1984
- Application: NDA018902
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 May 1985
- Application: ANDA070086
- Marketing authorisation holder: HIKMA
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1985
- Application: ANDA070043
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 1985
- Application: ANDA070450
- Marketing authorisation holder: WATSON LABS
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 1985
- Application: ANDA070449
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 1986
- Application: ANDA070528
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 1986
- Application: ANDA070412
- Marketing authorisation holder: WATSON LABS
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 1986
- Application: ANDA070413
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 October 1986
- Application: ANDA070082
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 December 1986
- Application: ANDA070017
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 January 1987
- Application: ANDA071379
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 April 1987
- Application: ANDA070433
- Marketing authorisation holder: HIKMA
- Local brand name: FUROSEMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 April 1987
- Application: ANDA070434
- Marketing authorisation holder: HIKMA
- Local brand name: FUROSEMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 1 October 1987
- Application: ANDA070655
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Local brand name: FUROSEMIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 January 1988
- Application: ANDA070100
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 1988
- Application: NDA018750
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 1989
- Application: NDA018370
- Marketing authorisation holder: SUPERPHARM
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 September 1990
- Application: ANDA071439
- Marketing authorisation holder: HIKMA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 August 1991
- Application: ANDA072080
- Marketing authorisation holder: HOSPIRA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 October 1994
- Application: ANDA074337
- Marketing authorisation holder: HOSPIRA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 1999
- Application: ANDA075241
- Marketing authorisation holder: HOSPIRA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 March 2004
- Application: ANDA076796
- Marketing authorisation holder: PRINSTON INC
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2006
- Application: ANDA078010
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2007
- Application: ANDA077941
- Marketing authorisation holder: APOTEX
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 April 2014
- Application: ANDA091258
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 2014
- Application: ANDA203428
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 July 2016
- Application: ANDA207552
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 May 2019
- Application: ANDA212174
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 July 2020
- Application: ANDA213902
- Marketing authorisation holder: GLAND
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 December 2020
- Application: ANDA208435
- Marketing authorisation holder: AREVA PHARMS
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 January 2021
- Application: ANDA214766
- Marketing authorisation holder: SAGENT
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 January 2022
- Application: ANDA212803
- Marketing authorisation holder: MEITHEAL
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 October 2022
- Application: NDA209988
- Marketing authorisation holder: SCPHARMACEUTICALS
- Local brand name: FUROSCIX
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 17 October 2022
- Application: ANDA216629
- Marketing authorisation holder: GRAVITI PHARMS
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 2022
- Application: ANDA216860
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 April 2024
- Application: ANDA215856
- Marketing authorisation holder: SABA ILAC SANAYIVE
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 December 2024
- Application: ANDA217557
- Marketing authorisation holder: ASPIRO
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 July 2025
- Application: ANDA218831
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 January 2026
- Application: ANDA218188
- Marketing authorisation holder: MICRO LABS
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070096
- Marketing authorisation holder: IGI LABS INC
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070095
- Marketing authorisation holder: IGI LABS INC
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA019036
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070023
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA018670
- Marketing authorisation holder: WYETH AYERST
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070019
- Marketing authorisation holder: WATSON LABS
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA018419
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070078
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA074017
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA018868
- Marketing authorisation holder: KALAPHARM
- Local brand name: FUROSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070014
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA018420
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: FUROSEMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Lasix 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 Lasix approved in United States?
Yes. FDA authorised it on 1 July 1966; FDA authorised it on 20 March 1968; FDA authorised it on 8 March 1977.
Who is the marketing authorisation holder for Lasix in United States?
VALIDUS PHARMS holds the US marketing authorisation.