Details for New Drug Application (NDA): 018225

✉ Email this page to a colleague

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. Twenty-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RX	Dosage:	TABLET;ORAL			Strength	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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RX	Dosage:	TABLET;ORAL			Strength	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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RX	Dosage:	TABLET;ORAL			Strength	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-002	Feb 28, 1983	⤷ Sign Up	⤷ Sign Up
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-001	Feb 28, 1983	⤷ Sign Up	⤷ Sign Up
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985	⤷ Sign Up	⤷ Sign Up
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985	⤷ Sign Up	⤷ Sign Up
Validus Pharms	BUMEX	bumetanide	TABLET;ORAL	018225-003	Jun 14, 1985	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.