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Details for New Drug Application (NDA): 065331

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NDA 065331 describes EPIRUBICIN HYDROCHLORIDE, which is a drug marketed by Hospira, Fresenius Kabi Usa, Fresenius Kabi Oncol, Impax Labs Inc, Ebewe Pharma, Actavis Totowa, Cipla Ltd, Akorn Inc, Mustafa Nevsat, Mylan Institutional, Hisun Pharm Hangzhou, West-ward Pharms Int, and Mylan Labs Ltd, and is included in fourteen NDAs. It is available from nine suppliers. Additional details are available on the EPIRUBICIN HYDROCHLORIDE profile page.

The generic ingredient in EPIRUBICIN HYDROCHLORIDE 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: 065331

Tradename:
EPIRUBICIN HYDROCHLORIDE
Applicant:
Impax Labs Inc
Ingredient:
epirubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065331

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 065331

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride
INJECTABLE;INJECTION 065331 ANDA Teva Parenteral Medicines, Inc. 0703-3067 0703-3067-11 1 VIAL, SINGLE-USE in 1 CARTON (0703-3067-11) > 25 mL in 1 VIAL, SINGLE-USE
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride
INJECTABLE;INJECTION 065331 ANDA Teva Parenteral Medicines, Inc. 0703-3069 0703-3069-11 1 VIAL, SINGLE-USE in 1 CARTON (0703-3069-11) > 100 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Aug 9, 2007TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Aug 9, 2007TE:APRLD:No


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