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Cerilliant
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050778

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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
Tradename:ELLENCE
Applicant:Pfizer Inc
Ingredient:epirubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050778
Ingredient-typeAnthracyclines
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

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Merck
Express Scripts
Cantor Fitzgerald
Cipla
US Army
Johnson and Johnson
Boehringer Ingelheim
Colorcon

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