Is there a generic for Furosemide?

Yes. The FDA Orange Book lists 47 approved generic (ANDA) applications for Furosemide, referencing the brand LASIX ONYU. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Furosemide?

LASIX ONYU (NDA 217294, SQ INNOVATION) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Furosemide?

The Orange Book lists 17 patents against Furosemide products, with the earliest listed expiry in 2034. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Furosemide are approved?

Furosemide is approved in the following dosage forms: injectable, solution, tablet.

FDA Orange Book · active-ingredient family

Furosemide

Furosemide: 26 brands, 47 generics; first approved Feb 26, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 47 ANDA applications approved.

Earliest patent expiry Apr 03, 2034

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Apr 03, 2034

in 7 yr 7 mo

Brand (NDA) products

Originator applications

LASIX ONYURLDRS
SQ INNOVATIONNDA 2172942025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
80MG/2.67ML (30MG/ML) SOLUTION SUBCUTANEOUS Rx —
FUROSCIXRLDRS
SCPHARMACEUTICALSNDA 20998820222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
80MG/10ML (8MG/ML) SOLUTION SUBCUTANEOUS Rx —
80MG/ML (80MG/ML) SOLUTION SUBCUTANEOUS Rx —
FUROSEMIDERLD
AM REGENTNDA 0185791983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
LASIXRLD
SANOFI AVENTIS USNDA 016363—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
LASIXRLD
SANOFI AVENTIS USNDA 017688—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML SOLUTION ORAL Discontinued —
LASIXRLD
VALIDUS PHARMSNDA 016273—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
80MG TABLET ORAL Discontinued —
FUROSEMIDE
ABRAXIS PHARMNDA 0190361984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
EPIC PHARMA LLCNDA 0187501984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG TABLET ORAL Discontinued —
FUROSEMIDE
SUPERPHARMNDA 01837019842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG TABLET ORAL Discontinued —
20MG TABLET ORAL Discontinued —
FUROSEMIDE
FRESENIUS KABI USANDA 0189021984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
INTL MEDICATIONNDA 01875319842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
40MG TABLET ORAL Discontinued —
FUROSEMIDE
CHARTWELL RXNDA 01841319832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
40MG TABLET ORAL Discontinued —
FUROSEMIDE
SUN PHARM INDS INCNDA 0187901983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG TABLET ORAL Discontinued —
FUROSEMIDE
HIKMANDA 01882319832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Rx AB
40MG TABLET ORAL Rx AB
FUROSEMIDE
KALAPHARMNDA 01886819832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
40MG TABLET ORAL Discontinued —
FUROSEMIDE
WARNER CHILCOTTNDA 01841919833 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
40MG TABLET ORAL Discontinued —
80MG TABLET ORAL Discontinued —
FUROSEMIDE
ABRAXIS PHARMNDA 0185071982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
ESJAY PHARMANDA 01841519823 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Rx AB
40MG TABLET ORAL Rx AB
80MG TABLET ORAL Rx AB
FUROSEMIDE
WYETH AYERSTNDA 0186701982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
HOSPIRANDA 0186671982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
WATSON LABSNDA 01836919822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
40MG TABLET ORAL Discontinued —
FUROSEMIDE
WARNER CHILCOTTNDA 0184201982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
HIKMANDA 018267—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
INTL MEDICATIONNDA 018025—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
EPIC PHARMA LLCNDA 018569—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
80MG TABLET ORAL Rx AB
FUROSEMIDE
PHARMOBEDIENTNDA 018487—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
40MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
80MG/2.67ML (30MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
80MG/10ML (8MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	—
80MG/ML (80MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	SOLUTION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—
80MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	TABLET	ORAL	Discontinued	—
20MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—
40MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—
40MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Rx	AB
40MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—
40MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—
40MG	TABLET	ORAL	Discontinued	—
80MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Rx	AB
40MG	TABLET	ORAL	Rx	AB
80MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—
40MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB
80MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—
40MG	TABLET	ORAL	Discontinued	—

Generic (ANDA) products (47)

Abbreviated applications

FUROSEMIDE
MICRO LABSANDA 2181882026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
AUROBINDO PHARMA LTDANDA 21883120253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Rx AB
40MG TABLET ORAL Rx AB
80MG TABLET ORAL Rx AB
FUROSEMIDE
ASPIROANDA 2175572024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
SABA ILAC SANAYIVEANDA 2158562024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
MANKIND PHARMAANDA 2168602022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
GRAVITI PHARMSANDA 21662920223 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Rx AB
40MG TABLET ORAL Rx AB
80MG TABLET ORAL Rx AB
FUROSEMIDE
MEITHEALANDA 2128032022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
SAGENTANDA 2147662021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
AREVA PHARMSANDA 2084352020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
GLANDANDA 2139022020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
EUGIA PHARMAANDA 2121742019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
AMNEAL PHARMS COANDA 2075522016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
AVET LIFESCIENCESANDA 2034282014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
SUN PHARM INDS INCANDA 09125820143 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
40MG TABLET ORAL Discontinued —
80MG TABLET ORAL Discontinued —
FUROSEMIDERS
BAXTER HLTHCARE CORPANDA 2027472014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
APOTEXANDA 0779412007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
IPCA LABS LTDANDA 07801020063 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Rx AB
40MG TABLET ORAL Rx AB
80MG TABLET ORAL Rx AB
FUROSEMIDE
LEADINGANDA 07729320053 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Rx AB
40MG TABLET ORAL Rx AB
80MG TABLET ORAL Rx AB
FUROSEMIDE
PRINSTON INCANDA 07679620043 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Rx AB
40MG TABLET ORAL Rx AB
80MG TABLET ORAL Rx AB
FUROSEMIDE
HOSPIRAANDA 0752411999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
HOSPIRAANDA 0743371994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
MARSAM PHARMS LLCANDA 0740171994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
HOSPIRAANDA 0720801991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
HIKMAANDA 0714391990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
ANI PHARMSANDA 0715941988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
80MG TABLET ORAL Discontinued —
FUROSEMIDE
SUN PHARM INDUSTRIESANDA 0701001988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
80MG TABLET ORAL Discontinued —
FUROSEMIDE
PHARMOBEDIENT CNSLTGANDA 0706551987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML SOLUTION ORAL Discontinued —
FUROSEMIDE
HOSPIRAANDA 0705781987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDERS
HIKMAANDA 0704341987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML SOLUTION ORAL Rx —
FUROSEMIDERS
HIKMAANDA 0704331987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/5ML SOLUTION ORAL Rx —
FUROSEMIDE
WATSON LABSANDA 0706041987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
ANI PHARMSANDA 0713791987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
FUROSEMIDE
ACCORD HLTHCAREANDA 0700171986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Rx AP
FUROSEMIDE
PHARMOBEDIENTANDA 0700821986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
80MG TABLET ORAL Discontinued —
FUROSEMIDE
WATSON LABSANDA 0700191986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
ANI PHARMSANDA 0704131986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG TABLET ORAL Discontinued —
FUROSEMIDE
WATSON LABSANDA 0704121986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
FUROSEMIDE
SMITH AND NEPHEWANDA 0700231986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
SMITH AND NEPHEWANDA 0700781986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
HIKMAANDA 0700861986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
80MG TABLET ORAL Rx AB
FUROSEMIDE
WATSON LABS TEVAANDA 0705281986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
80MG TABLET ORAL Discontinued —
FUROSEMIDE
WATSON LABSANDA 0704501985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG TABLET ORAL Discontinued —
FUROSEMIDE
WATSON LABS TEVAANDA 0704491985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
FUROSEMIDE
SUN PHARM INDUSTRIESANDA 0700431985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued —
FUROSEMIDE
ASTRAZENECAANDA 0700141985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
IGI LABS INCANDA 0700951985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
FUROSEMIDE
IGI LABS INCANDA 0700961985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Rx	AB
40MG	TABLET	ORAL	Rx	AB
80MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Rx	AB
40MG	TABLET	ORAL	Rx	AB
80MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	—
40MG	TABLET	ORAL	Discontinued	—
80MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Rx	AB
40MG	TABLET	ORAL	Rx	AB
80MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Rx	AB
40MG	TABLET	ORAL	Rx	AB
80MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Rx	AB
40MG	TABLET	ORAL	Rx	AB
80MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11433044	Apr 03, 2034	in 7 yr 7 mo	U-3462
9884039	Apr 03, 2034	in 7 yr 7 mo	U-3462
12370168	Apr 03, 2034	in 7 yr 7 mo	ProductU-3462
10272064	Apr 03, 2034	in 7 yr 7 mo	Product
11246851	Jan 03, 2040	in 13 yr 5 mo	ProductU-4576
12318363	Jan 03, 2040	in 13 yr 5 mo	Product
12491197	Jan 30, 2040	in 13 yr 6 mo	ProductU-4588
12491196	Jan 30, 2040	in 13 yr 6 mo	ProductU-4588
12491195	Jan 30, 2040	in 13 yr 6 mo	ProductU-4588
12491194	Jan 30, 2040	in 13 yr 6 mo	ProductU-4588
12491193	Jan 30, 2040	in 13 yr 6 mo	ProductU-4588
12048709	Jan 30, 2040	in 13 yr 6 mo	ProductU-4588
11998555	Jan 30, 2040	in 13 yr 6 mo	ProductU-4589
11559535	Jan 30, 2040	in 13 yr 6 mo	Product
11571434	Jan 30, 2040	in 13 yr 6 mo	Product
11497755	Jan 30, 2040	in 13 yr 6 mo	Product
12403120	Jan 10, 2042	in 15 yr 5 mo	ProductU-4576

Approval history

FDA approval span

First approval

Feb 26, 1982

45 yr 3 mo ago

Most recent approval

Jul 23, 2026

3 mo ago

Approvals span 1982–2026 across 73 FDA applications.

Brand (NDA) 2636%

Generic (ANDA) 4764%

Furosemide: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Go beyond the database.

Try Assyro Intelligence for your regulatory research. Ready to discuss your team’s workflow? Book a demo.

Try Assyro Intelligence for free Book a demo