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)

26

Generics (ANDA)

47

Listed patents

4

Next patent expiry

Apr 03, 2034

in 7 yr 10 mo

Originator applications

Brand (NDA) products

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	—

SCPHARMACEUTICALSNDA 2099882022

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

AM REGENTNDA 0185791983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

SANOFI AVENTIS USNDA 016363—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

SANOFI AVENTIS USNDA 017688—

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

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	—

ABRAXIS PHARMNDA 0190361984

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

EPIC PHARMA LLCNDA 0187501984

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

SUPERPHARMNDA 01837019842 strengths

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

FRESENIUS KABI USANDA 0189021984

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

INTL MEDICATIONNDA 01875319842 strengths

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

CHARTWELL RXNDA 01841319832 strengths

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

SUN PHARM INDS INCNDA 0187901983

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

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

KALAPHARMNDA 01886819832 strengths

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

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	—

ABRAXIS PHARMNDA 0185071982

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

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

WYETH AYERSTNDA 0186701982

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

HOSPIRANDA 0186671982

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

WATSON LABSNDA 01836919822 strengths

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

WARNER CHILCOTTNDA 0184201982

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

HIKMANDA 018267—

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

INTL MEDICATIONNDA 018025—

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

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

PHARMOBEDIENTNDA 018487—2 strengths

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

Abbreviated applications

Generic (ANDA) products (47)

MICRO LABSANDA 2181882026

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

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

ASPIROANDA 2175572024

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

SABA ILAC SANAYIVEANDA 2158562024

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

MANKIND PHARMAANDA 2168602022

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

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

MEITHEALANDA 2128032022

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

SAGENTANDA 2147662021

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

AREVA PHARMSANDA 2084352020

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

GLANDANDA 2139022020

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

EUGIA PHARMAANDA 2121742019

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

AMNEAL PHARMS COANDA 2075522016

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

AVET LIFESCIENCESANDA 2034282014

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

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	—

BAXTER HLTHCARE CORPANDA 2027472014

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

APOTEXANDA 0779412007

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

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

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

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

HOSPIRAANDA 0752411999

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

HOSPIRAANDA 0743371994

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

MARSAM PHARMS LLCANDA 0740171994

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

HOSPIRAANDA 0720801991

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

HIKMAANDA 0714391990

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

ANI PHARMSANDA 0715941988

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

SUN PHARM INDUSTRIESANDA 0701001988

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

PHARMOBEDIENT CNSLTGANDA 0706551987

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

HOSPIRAANDA 0705781987

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

HIKMAANDA 0704341987

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

HIKMAANDA 0704331987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/5ML	SOLUTION	ORAL	Rx	—

WATSON LABSANDA 0706041987

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

ANI PHARMSANDA 0713791987

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

ACCORD HLTHCAREANDA 0700171986

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

PHARMOBEDIENTANDA 0700821986

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

WATSON LABSANDA 0700191986

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

ANI PHARMSANDA 0704131986

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

WATSON LABSANDA 0704121986

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

SMITH AND NEPHEWANDA 0700231986

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

SMITH AND NEPHEWANDA 0700781986

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

HIKMAANDA 0700861986

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

WATSON LABS TEVAANDA 0705281986

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

WATSON LABSANDA 0704501985

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

WATSON LABS TEVAANDA 0704491985

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

SUN PHARM INDUSTRIESANDA 0700431985

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

ASTRAZENECAANDA 0700141985

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

IGI LABS INCANDA 0700951985

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

IGI LABS INCANDA 0700961985

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

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (4)

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 10 mo	U-3462
9884039	Apr 03, 2034	in 7 yr 10 mo	U-3462
12370168	Apr 03, 2034	in 7 yr 10 mo	ProductU-3462
10272064	Apr 03, 2034	in 7 yr 10 mo	Product

FDA approval span

Approval history

First approval

Feb 26, 1982

45 yr ago

Most recent approval

Jan 08, 2026

6 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.

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