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Generated: September 19, 2017

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 Mylan Institutional and Luitpold 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. Four suppliers are listed for this compound. Additional details are available on the ibutilide fumarate profile page.

Summary for NDA: 090643

Tradename:
1
Applicant:
1
Ingredient:
1
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

Summary 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 500+ biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Baxter
Chinese Patent Office
AstraZeneca
Dow
Queensland Health
Citi
Covington
QuintilesIMS

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