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Details for New Drug Application (NDA): 065445

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NDA 065445 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: 065445

Tradename:
EPIRUBICIN HYDROCHLORIDE
Applicant:
Actavis Totowa
Ingredient:
epirubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065445

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 065445

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride
INJECTABLE;INJECTION 065445 ANDA Impax Generics 0115-1675 0115-1675-72 1 VIAL, SINGLE-USE in 1 CARTON (0115-1675-72) > 25 mL in 1 VIAL, SINGLE-USE
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride
INJECTABLE;INJECTION 065445 ANDA Impax Generics 0115-1675 0115-1675-73 1 VIAL, SINGLE-USE in 1 CARTON (0115-1675-73) > 100 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/5ML (2MG/ML)
Approval Date:Sep 18, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Sep 18, 2008TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Sep 18, 2008TE:APRLD:No


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