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Serving 500+ biopharmaceutical companies globally:

Argus Health
Farmers Insurance
Daiichi Sankyo
Boehringer Ingelheim
US Army

Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065361

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NDA 065361 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 nine 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: 065361

Formulation / Manufacturing:see details

Pharmacology for NDA: 065361

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 065361

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
epirubicin hydrochloride
INJECTABLE;INJECTION 065361 ANDA Sagent Pharmaceuticals 25021-203 25021-203-25 1 VIAL in 1 CARTON (25021-203-25) > 25 mL in 1 VIAL
epirubicin hydrochloride
INJECTABLE;INJECTION 065361 ANDA Sagent Pharmaceuticals 25021-203 25021-203-51 1 VIAL in 1 CARTON (25021-203-51) > 100 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/25ML (2MG/ML)
Approval Date:Oct 22, 2007TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Oct 22, 2007TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Argus Health
Fish and Richardson
Daiichi Sankyo
US Department of Justice
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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