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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065289

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NDA 065289 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 ten suppliers. Additional details are available on the EPIRUBICIN HYDROCHLORIDE profile page.

The generic ingredient in EPIRUBICIN HYDROCHLORIDE is epirubicin hydrochloride. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.

Summary for NDA: 065289

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065289

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 065289

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride
INJECTABLE;INJECTION 065289 ANDA West-Ward Pharmaceuticals Corp 0143-9202 0143-9202-01 1 VIAL in 1 BOX (0143-9202-01) > 25 mL in 1 VIAL
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride
INJECTABLE;INJECTION 065289 ANDA West-Ward Pharmaceuticals Corp 0143-9203 0143-9203-01 1 VIAL in 1 BOX (0143-9203-01) > 50 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Jun 27, 2007TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Jun 27, 2007TE:APRLD:No


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Argus Health
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