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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090643

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NDA 090643 describes IBUTILIDE FUMARATE, which is a drug marketed by Luitpold and Mylan Institutional and is included in three NDAs. It is available from one supplier. Additional details are available on the IBUTILIDE FUMARATE profile page.

The generic ingredient in IBUTILIDE FUMARATE is ibutilide fumarate. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ibutilide fumarate profile page.
Summary for 090643
Tradename:IBUTILIDE FUMARATE
Applicant:Mylan Institutional
Ingredient:ibutilide fumarate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090643
Suppliers and Packaging for NDA: 090643
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUTILIDE FUMARATE ibutilide fumarate INJECTABLE;INJECTION 090643 ANDA Mylan Institutional LLC 67457-366 N 67457-366-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.1MG/ML
Approval Date:Jan 11, 2010TE:APRLD:No

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