Details for New Drug Application (NDA): 065289
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NDA 065289 describes EPIRUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Totowa, Cipla Ltd, Ebewe Pharma, Epic Pharma Llc, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Norvium Bioscience, and Zennova, and is included in fourteen NDAs. It is available from one supplier. 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. Two suppliers are listed for this compound. 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. Two suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.
Summary for 065289
| Tradename: | EPIRUBICIN HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | epirubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 065289
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 065289
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 | Hikma Pharmaceuticals USA Inc. | 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 | Hikma Pharmaceuticals USA Inc. | 0143-9203 | 0143-9203-01 | 1 VIAL in 1 BOX (0143-9203-01) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/25ML (2MG/ML) | ||||
| Approval Date: | Jun 27, 2007 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML (2MG/ML) | ||||
| Approval Date: | Jun 27, 2007 | TE: | AP | RLD: | No | ||||
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