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Epirubicin hydrochlorideis the generic ingredient in two branded drugs marketed by Pfizer Inc, Actavis Totowa, Akorn Inc, Cipla Ltd, Ebewe Pharma, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Mylan Institutional, Mylan Labs Ltd, West-ward Pharms Int, and Zennova, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.
There are nine drug master file entries for epirubicin hydrochloride. Four suppliers are listed for this compound.
Recent Clinical Trials for epirubicin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|The First Affiliated Hospital with Nanjing Medical University||Phase 2|
|Providence Health & Services||Phase 1|
|Second Affiliated Hospital, School of Medicine, Zhejiang University||Phase 2/Phase 3|
Pharmacology for epirubicin hydrochloride
|Drug Class||Anthracycline Topoisomerase Inhibitor |
|Mechanism of Action||Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for epirubicin hydrochloride
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Fresenius Kabi Usa||EPIRUBICIN HYDROCHLORIDE||epirubicin hydrochloride||INJECTABLE;INJECTION||065411-002||Aug 20, 2007||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Fresenius Kabi Usa||EPIRUBICIN HYDROCHLORIDE||epirubicin hydrochloride||INJECTABLE;INJECTION||065408-003||Oct 15, 2007||RX||No||No||Start Trial||Start Trial||Start Trial|
|Hospira||EPIRUBICIN HYDROCHLORIDE||epirubicin hydrochloride||INJECTABLE;INJECTION||065343-003||Apr 19, 2007||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Impax Labs Inc||EPIRUBICIN HYDROCHLORIDE||epirubicin hydrochloride||INJECTABLE;INJECTION||065331-002||Aug 9, 2007||AP||RX||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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