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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 eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.

Summary for NDA: 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

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 0009-5091-01 1 VIAL, SINGLE-USE in 1 CARTON (0009-5091-01) > 25 mL in 1 VIAL, SINGLE-USE
ELLENCE
epirubicin hydrochloride
INJECTABLE;INJECTION 050778 NDA Pharmacia and Upjohn Company LLC 0009-5093 0009-5093-01 1 VIAL, SINGLE-USE in 1 CARTON (0009-5093-01) > 100 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Sep 15, 1999TE:APRLD:No


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