Tools / Drug approvals and letters / Drugs Furosemide Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. Sold as Lasix, Furosemide, Furoscix, Furoscix Readyflow, Lasix Onyu. Every FDA application for this active ingredient: 26 branded and 47 generic.
As of Nov 13, 2026, FDA lists 73 applications for Furosemide (sold as Lasix, Furosemide, Furoscix and others), first approved Jul 1, 1966, with 6 new uses approved and 3 published complete response letters.
First approved : Jul 1, 1966 Applications : 73 New uses approved : 6 Complete response letters : 3 Medicare spending, 2024 : $147M Shortage : Current
Medicare Spending CMS Part D and Part B, 2024, before manufacturer rebates; matched by generic name Product Part Spending, 2024 Change Beneficiaries Furosemide Part D $119M -18% 5,790,198 Furoscix Part D $27.2M +217% 3,059 Lasix Part D $507K -17% 2,262 Furosemide Part B $30K -21% 16,747
Shortages FDA's drug shortage list, as of Nov 13, 2026
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Jul 1, 1966 Lasix NDA 16273 · New molecular entity Validus Pharms36 Discontinued Mar 20, 1968 Lasix NDA 16363 · New dosage form Sanofi Aventis US43 Discontinued Mar 8, 1977 Lasix NDA 17688 · New dosage form Sanofi Aventis US22 Discontinued Jan 10, 1979 Furosemide NDA 18025 Intl Medication16 Discontinued May 19, 1981 Furosemide NDA 18267 Hikma17 Marketed Aug 27, 1981 Furosemide NDA 18487 Pharmobedient22 Discontinued Oct 19, 1981 Furosemide NDA 18569 · New formulation or manufacturer Epic Pharma LLC33 Marketed May 14, 1982 Furosemide NDA 18369 Watson Labs0 Discontinued May 28, 1982 Furosemide NDA 18667 Hospira18 Marketed Jul 27, 1982 Furosemide NDA 18415 Esjay Pharma17 Marketed Oct 6, 1983 Furosemide NDA 18790 Sun Pharm Inds Inc25 Discontinued Nov 10, 1983 Furosemide NDA 18823 Hikma34 Marketed Nov 30, 1983 Furosemide NDA 18413 Chartwell Rx37 Discontinued Nov 30, 1983 Furosemide NDA 18579 Am Regent23 Discontinued Feb 28, 1984 Furosemide NDA 18753 Intl Medication0 Discontinued May 22, 1984 Furosemide NDA 18902 · New formulation or manufacturer Fresenius Kabi USA20 Marketed Sep 26, 1985 Furosemide ANDA 70043 Sun Pharm Industries15 Discontinued Nov 22, 1985 Furosemide ANDA 70449 Watson Labs Teva23 Discontinued Nov 22, 1985 Furosemide ANDA 70450 Watson Labs22 Discontinued Jan 7, 1986 Furosemide ANDA 70528 Watson Labs Teva23 Discontinued Jan 24, 1986 Furosemide ANDA 70086 Hikma31 Marketed Feb 26, 1986 Furosemide ANDA 70412 Watson Labs10 Discontinued Feb 26, 1986 Furosemide ANDA 70413 Ani Pharms8 Discontinued Oct 29, 1986 Furosemide ANDA 70082 Pharmobedient19 Discontinued Dec 15, 1986 Furosemide ANDA 70017 Accord Hlthcare0 Marketed Jan 2, 1987 Furosemide ANDA 71379 Ani Pharms20 Discontinued Apr 22, 1987 Furosemide ANDA 70433 Hikma25 Marketed Apr 22, 1987 Furosemide ANDA 70434 Hikma31 Marketed Jul 8, 1987 Furosemide ANDA 70578 Hospira11 Discontinued Oct 1, 1987 Furosemide ANDA 70655 Pharmobedient Cnsltg13 Discontinued Jan 26, 1988 Furosemide ANDA 70100 Sun Pharm Industries10 Discontinued Feb 9, 1988 Furosemide ANDA 71594 Ani Pharms9 Discontinued Sep 14, 1990 Furosemide ANDA 71439 Hikma0 Discontinued Aug 13, 1991 Furosemide ANDA 72080 Hospira5 Discontinued Sep 16, 1994 Furosemide NDA 18750 Epic Pharma LLC1 Discontinued Oct 31, 1994 Furosemide ANDA 74337 Hospira1 Discontinued May 28, 1999 Furosemide ANDA 75241 Hospira4 Marketed Mar 26, 2004 Furosemide ANDA 76796 Prinston7 Marketed Nov 9, 2005 Furosemide ANDA 77293 Leading3 Marketed Sep 18, 2006 Furosemide ANDA 78010 Ipca Labs Ltd5 Marketed Mar 22, 2007 Furosemide ANDA 77941 Apotex1 Marketed Jan 27, 2014 Furosemide ANDA 202747 Baxter Hlthcare Corp1 Marketed Apr 1, 2014 Furosemide ANDA 91258 Sun Pharm Inds Inc0 Discontinued Aug 26, 2014 Furosemide ANDA 203428 Avet Lifesciences2 Marketed Jul 20, 2016 Furosemide ANDA 207552 Amneal Pharms Co0 Discontinued May 3, 2019 Furosemide ANDA 212174 Eugia Pharma1 Marketed Jul 1, 2020 Furosemide ANDA 213902 Gland0 Marketed Dec 18, 2020 Furosemide ANDA 208435 Areva Pharms0 Marketed Jan 27, 2021 Furosemide ANDA 214766 Sagent0 Marketed Jan 27, 2022 Furosemide ANDA 212803 Meitheal1 Marketed Oct 7, 2022 Furoscix, Furoscix Readyflow NDA 209988 · New dosage form Scpharmaceuticals4 Marketed Oct 17, 2022 Furosemide ANDA 216629 Graviti Pharms0 Marketed Dec 16, 2022 Furosemide ANDA 216860 Mankind Pharma0 Marketed Apr 2, 2024 Furosemide ANDA 215856 Saba Ilac Sanayive0 Marketed Dec 13, 2024 Furosemide ANDA 217557 Aspiro0 Marketed Jul 17, 2025 Furosemide ANDA 218831 Aurobindo Pharma Ltd0 Marketed Oct 7, 2025 Lasix Onyu NDA 217294 · New dosage form Sq Innovation0 Marketed Jan 8, 2026 Furosemide ANDA 218188 Micro Labs0 Marketed — Furosemide ANDA 70014 Astrazeneca0 Discontinued — Furosemide ANDA 70019 Watson Labs0 Discontinued — Furosemide ANDA 70023 Smith And Nephew0 Discontinued — Furosemide ANDA 70078 Smith And Nephew0 Discontinued — Furosemide ANDA 70095 Igi Labs Inc0 Discontinued — Furosemide ANDA 70096 Igi Labs Inc0 Discontinued — Furosemide ANDA 70604 Watson Labs0 Discontinued — Furosemide ANDA 74017 Marsam Pharms LLC0 Discontinued — Furosemide NDA 18370 Superpharm3 Discontinued — Furosemide NDA 18419 Warner Chilcott0 Discontinued — Furosemide NDA 18420 Warner Chilcott0 Discontinued — Furosemide NDA 18507 Abraxis Pharm0 Discontinued — Furosemide NDA 18670 Wyeth Ayerst0 Discontinued — Furosemide NDA 18868 Kalapharm0 Discontinued — Furosemide NDA 19036 Abraxis Pharm0 Discontinued
Show all 73
Complete Response Letters FDA's published letters for these applications Letter Product Now Jan 12, 2024 Furosemide Product Quality Unapproved Dec 3, 2020 NDA 209988 Facility Inspections Approved Jun 11, 2018 NDA 209988 Cdrh/Device, Drug Product Quality, Clinical Approved
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA