BioPharmaceutical Business Intelligence

  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Express Scripts
Boehringer Ingelheim
Farmers Insurance

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090643

« Back to Dashboard

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
Applicant:Mylan Institutional
Ingredient:ibutilide fumarate
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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Fish and Richardson
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.