Last Updated: May 3, 2026

Details for New Drug Application (NDA): 018226

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NDA 018226 describes BUMEX, which is a drug marketed by Validus Pharms and is included in two NDAs. It is available from three suppliers. Additional details are available on the BUMEX profile page.

The generic ingredient in BUMEX is bumetanide. There are six drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the bumetanide profile page.

Summary for 018226

Tradename:	BUMEX
Applicant:	Validus Pharms
Ingredient:	bumetanide
Patents:	0

Medical Subject Heading (MeSH) Categories for 018226

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 28, 1983	TE:		RLD:	Yes

Expired US Patents for NDA 018226

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	BUMEX	bumetanide	INJECTABLE;INJECTION	018226-001	Feb 28, 1983	3,634,583	⤷ Start Trial
Validus Pharms	BUMEX	bumetanide	INJECTABLE;INJECTION	018226-001	Feb 28, 1983	3,806,534	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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