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Last Updated: July 2, 2020

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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 six drug master file entries for this compound. Twenty-two 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 018225
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 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: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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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   Start Trial   Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-003 Jun 14, 1985   Start Trial   Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-002 Feb 28, 1983   Start Trial   Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-003 Jun 14, 1985   Start Trial   Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-001 Feb 28, 1983   Start Trial   Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-001 Feb 28, 1983   Start Trial   Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-002 Feb 28, 1983   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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