Details for New Drug Application (NDA): 018225

NDA 018225 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the bumetanide profile page.

Summary for 018225

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

Pharmacology for NDA: 018225

Physiological Effect

Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 018225

Diuretics

Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 018225

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUMEX	bumetanide	TABLET;ORAL	018225	NDA	Validus Pharmaceuticals LLC	30698-630	30698-630-01	100 TABLET in 1 BOTTLE (30698-630-01)
BUMEX	bumetanide	TABLET;ORAL	018225	NDA	Validus Pharmaceuticals LLC	30698-631	30698-631-01	100 TABLET in 1 BOTTLE (30698-631-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 28, 1983	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 28, 1983	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Jun 14, 1985	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018225

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-002	Feb 28, 1983
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-001	Feb 28, 1983
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-001	Feb 28, 1983
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-002	Feb 28, 1983

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