FDA Orange Book · active-ingredient family
Furosemide
Furosemide is approved as 26 brand and 47 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LASIX ONYU · NDA 217294
26
Brand (NDA)
47
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LASIX ONYURLD | SQ INNOVATION | NDA 217294 | — | Oct 07, 2025 | |
| FUROSCIXRLD | SCPHARMACEUTICALS | NDA 209988 | — | Oct 07, 2022 | |
| FUROSEMIDERLD | AM REGENT | NDA 018579 | — | Nov 30, 1983 | |
| LASIXRLD | SANOFI AVENTIS US | NDA 016363 | — | Approved Prior to Jan 1, 1982 | |
| LASIXRLD | SANOFI AVENTIS US | NDA 017688 | — | Approved Prior to Jan 1, 1982 | |
| LASIXRLD×3 | VALIDUS PHARMS | NDA 016273 | — | Approved Prior to Jan 1, 1982 | |
| FUROSEMIDE | ABRAXIS PHARM | NDA 019036 | — | Aug 13, 1984 | |
| FUROSEMIDE | EPIC PHARMA LLC | NDA 018750 | — | Jul 30, 1984 | |
| FUROSEMIDE×2 | SUPERPHARM | NDA 018370 | — | Jun 26, 1984 | |
| FUROSEMIDE | FRESENIUS KABI USA | NDA 018902 | AP | May 22, 1984 | |
| FUROSEMIDE×2 | INTL MEDICATION | NDA 018753 | — | Feb 28, 1984 | |
| FUROSEMIDE×2 | CHARTWELL RX | NDA 018413 | — | Nov 30, 1983 | |
| FUROSEMIDE | SUN PHARM INDS INC | NDA 018790 | — | Nov 29, 1983 | |
| FUROSEMIDE×2 | HIKMA | NDA 018823 | AB | Nov 10, 1983 | |
| FUROSEMIDE×2 | KALAPHARM | NDA 018868 | — | Jun 28, 1983 | |
| FUROSEMIDE×3 | WARNER CHILCOTT | NDA 018419 | — | Jan 31, 1983 | |
| FUROSEMIDE | ABRAXIS PHARM | NDA 018507 | — | Jul 30, 1982 | |
| FUROSEMIDE×3 | ESJAY PHARMA | NDA 018415 | AB | Jul 27, 1982 | |
| FUROSEMIDE | WYETH AYERST | NDA 018670 | — | Jul 20, 1982 | |
| FUROSEMIDE | HOSPIRA | NDA 018667 | AP | May 28, 1982 | |
| FUROSEMIDE×2 | WATSON LABS | NDA 018369 | — | May 14, 1982 | |
| FUROSEMIDE | WARNER CHILCOTT | NDA 018420 | — | Feb 26, 1982 | |
| FUROSEMIDE | HIKMA | NDA 018267 | AP | Approved Prior to Jan 1, 1982 | |
| FUROSEMIDE | INTL MEDICATION | NDA 018025 | — | Approved Prior to Jan 1, 1982 | |
| FUROSEMIDE×3 | EPIC PHARMA LLC | NDA 018569 | AB | Approved Prior to Jan 1, 1982 | |
| FUROSEMIDE×2 | PHARMOBEDIENT | NDA 018487 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (47)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FUROSEMIDE | MICRO LABS | ANDA 218188 | AP | Jan 08, 2026 | |
| FUROSEMIDE×3 | AUROBINDO PHARMA LTD | ANDA 218831 | AB | Jul 17, 2025 | |
| FUROSEMIDE | ASPIRO | ANDA 217557 | AP | Dec 13, 2024 | |
| FUROSEMIDE | SABA ILAC SANAYIVE | ANDA 215856 | AP | Apr 02, 2024 | |
| FUROSEMIDE | MANKIND PHARMA | ANDA 216860 | AP | Dec 16, 2022 | |
| FUROSEMIDE×3 | GRAVITI PHARMS | ANDA 216629 | AB | Oct 17, 2022 | |
| FUROSEMIDE | MEITHEAL | ANDA 212803 | AP | Jan 27, 2022 | |
| FUROSEMIDE | SAGENT | ANDA 214766 | AP | Jan 27, 2021 | |
| FUROSEMIDE | AREVA PHARMS | ANDA 208435 | AP | Dec 18, 2020 | |
| FUROSEMIDE | GLAND | ANDA 213902 | AP | Jul 01, 2020 | |
| FUROSEMIDE | EUGIA PHARMA | ANDA 212174 | AP | May 03, 2019 | |
| FUROSEMIDE | AMNEAL PHARMS CO | ANDA 207552 | AP | Jul 20, 2016 | |
| FUROSEMIDE | AVET LIFESCIENCES | ANDA 203428 | AP | Aug 26, 2014 | |
| FUROSEMIDE×3 | SUN PHARM INDS INC | ANDA 091258 | — | Apr 01, 2014 | |
| FUROSEMIDE | BAXTER HLTHCARE CORP | ANDA 202747 | AP | Jan 27, 2014 | |
| FUROSEMIDE | APOTEX | ANDA 077941 | AP | Mar 22, 2007 | |
| FUROSEMIDE×3 | IPCA LABS LTD | ANDA 078010 | AB | Sep 18, 2006 | |
| FUROSEMIDE×3 | LEADING | ANDA 077293 | AB | Nov 09, 2005 | |
| FUROSEMIDE×3 | PRINSTON INC | ANDA 076796 | AB | Mar 26, 2004 | |
| FUROSEMIDE | HOSPIRA | ANDA 075241 | AP | May 28, 1999 | |
| FUROSEMIDE | HOSPIRA | ANDA 074337 | — | Oct 31, 1994 | |
| FUROSEMIDE | MARSAM PHARMS LLC | ANDA 074017 | — | Jun 30, 1994 | |
| FUROSEMIDE | HOSPIRA | ANDA 072080 | — | Aug 13, 1991 | |
| FUROSEMIDE | HIKMA | ANDA 071439 | — | Sep 14, 1990 | |
| FUROSEMIDE | ANI PHARMS | ANDA 071594 | — | Feb 09, 1988 | |
| FUROSEMIDE | SUN PHARM INDUSTRIES | ANDA 070100 | — | Jan 26, 1988 | |
| FUROSEMIDE | PHARMOBEDIENT CNSLTG | ANDA 070655 | — | Oct 02, 1987 | |
| FUROSEMIDE | HOSPIRA | ANDA 070578 | — | Jul 08, 1987 | |
| FUROSEMIDE | HIKMA | ANDA 070434 | — | Apr 22, 1987 | |
| FUROSEMIDE | HIKMA | ANDA 070433 | — | Apr 22, 1987 | |
| FUROSEMIDE | WATSON LABS | ANDA 070604 | — | Jan 02, 1987 | |
| FUROSEMIDE | ANI PHARMS | ANDA 071379 | — | Jan 02, 1987 | |
| FUROSEMIDE | ACCORD HLTHCARE | ANDA 070017 | AP | Dec 15, 1986 | |
| FUROSEMIDE | PHARMOBEDIENT | ANDA 070082 | — | Oct 29, 1986 | |
| FUROSEMIDE | WATSON LABS | ANDA 070019 | — | Sep 22, 1986 | |
| FUROSEMIDE | ANI PHARMS | ANDA 070413 | — | Feb 26, 1986 | |
| FUROSEMIDE | WATSON LABS | ANDA 070412 | — | Feb 26, 1986 | |
| FUROSEMIDE | SMITH AND NEPHEW | ANDA 070023 | — | Feb 05, 1986 | |
| FUROSEMIDE | SMITH AND NEPHEW | ANDA 070078 | — | Feb 05, 1986 | |
| FUROSEMIDE | HIKMA | ANDA 070086 | AB | Jan 24, 1986 | |
| FUROSEMIDE | WATSON LABS TEVA | ANDA 070528 | — | Jan 07, 1986 | |
| FUROSEMIDE | WATSON LABS | ANDA 070450 | — | Nov 22, 1985 | |
| FUROSEMIDE | WATSON LABS TEVA | ANDA 070449 | — | Nov 22, 1985 | |
| FUROSEMIDE | SUN PHARM INDUSTRIES | ANDA 070043 | — | Sep 26, 1985 | |
| FUROSEMIDE | ASTRAZENECA | ANDA 070014 | — | Sep 09, 1985 | |
| FUROSEMIDE | IGI LABS INC | ANDA 070095 | — | Sep 09, 1985 | |
| FUROSEMIDE | IGI LABS INC | ANDA 070096 | — | Sep 09, 1985 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11433044 | Apr 03, 2034 | in 7 yr 11 mo | U-3462 |
| 9884039 | Apr 03, 2034 | in 7 yr 11 mo | U-3462 |
| 12370168 | Apr 03, 2034 | in 7 yr 11 mo | ProductU-3462 |
| 10272064 | Apr 03, 2034 | in 7 yr 11 mo | Product |
Furosemide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
