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Last Updated: April 29, 2024

Details for New Drug Application (NDA): 016273

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NDA 016273 describes LASIX, which is a drug marketed by Sanofi Aventis Us and Validus Pharms and is included in three NDAs. It is available from one supplier. Additional details are available on the LASIX profile page.

The generic ingredient in LASIX is furosemide. There are twenty-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for 016273

Tradename:	LASIX
Applicant:	Validus Pharms
Ingredient:	furosemide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 016273

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 016273

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 016273

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LASIX	furosemide	TABLET;ORAL	016273	NDA	Validus Pharmaceuticals LLC	30698-060	30698-060-01	100 TABLET in 1 BOTTLE (30698-060-01)
LASIX	furosemide	TABLET;ORAL	016273	NDA	Validus Pharmaceuticals LLC	30698-060	30698-060-10	1000 TABLET in 1 BOTTLE (30698-060-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 016273

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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