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

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
US Army
Chinese Patent Office
Boehringer Ingelheim

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050778

« Back to Dashboard

NDA 050778 describes ELLENCE, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the ELLENCE profile page.

The generic ingredient in ELLENCE is epirubicin hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.
Summary for 050778
Applicant:Pfizer Inc
Ingredient:epirubicin hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 050778
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 050778
Suppliers and Packaging for NDA: 050778
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELLENCE epirubicin hydrochloride INJECTABLE;INJECTION 050778 NDA Pharmacia and Upjohn Company LLC 0009-5091 N 0009-5091-01
ELLENCE epirubicin hydrochloride INJECTABLE;INJECTION 050778 NDA Pharmacia and Upjohn Company LLC 0009-5093 N 0009-5093-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Sep 15, 1999TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Sep 15, 1999TE:APRLD:Yes

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
US Army
Johnson and Johnson
Boehringer Ingelheim

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.