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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Baxter
Mallinckrodt
Queensland Health
Fish and Richardson
Boehringer Ingelheim
AstraZeneca
Daiichi Sankyo
Medtronic

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018225

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NDA 018225 describes BUMEX, which is a drug marketed by Validus Pharms and is included in two NDAs. It is available from four suppliers. Additional details are available on the BUMEX profile page.

The generic ingredient in BUMEX is bumetanide. There are five drug master file entries for this compound. Twenty-one 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
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018225
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 AUTHORIZED GENERIC Edenbridge Pharmaceuticals, LLC 42799-119 N 42799-119-01
BUMEX bumetanide TABLET;ORAL 018225 NDA AUTHORIZED GENERIC Edenbridge Pharmaceuticals, LLC 42799-120 N 42799-120-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 28, 1983TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 28, 1983TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 14, 1985TE:ABRLD: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 ➤ 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 018225-001 Feb 28, 1983 ➤ Sign Up ➤ Sign Up
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-002 Feb 28, 1983 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Merck
Accenture
Fish and Richardson
UBS
Cipla
Cerilliant
Covington
McKesson

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