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Serving leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Colorcon
Express Scripts
Moodys
Cipla
UBS
Boehringer Ingelheim
Accenture
Farmers Insurance

Generated: January 20, 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 two suppliers. 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. Three 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 67457-366-10 1 VIAL, GLASS in 1 CARTON (67457-366-10) > 10 mL in 1 VIAL, GLASS

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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Serving leading biopharmaceutical companies globally:

Fuji
Johnson and Johnson
UBS
Chinese Patent Office
Fish and Richardson
Merck
Teva
Citi
Queensland Health

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