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Details for New Drug Application (NDA): 065361
The generic ingredient in EPIRUBICIN HYDROCHLORIDE is epirubicin hydrochloride. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the epirubicin hydrochloride profile page.
Summary for 065361
Tradename: | EPIRUBICIN HYDROCHLORIDE |
Applicant: | Cipla Ltd |
Ingredient: | epirubicin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065361
Ingredient-type | Anthracyclines |
Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 065361
Suppliers and Packaging for NDA: 065361
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065361 | ANDA | Sagent Pharmaceuticals | 25021-203 | N | 25021-203-51 |
EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065361 | ANDA | Sagent Pharmaceuticals | 25021-203 | N | 25021-203-25 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/25ML (2MG/ML) | ||||
Approval Date: | Oct 22, 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: | Oct 22, 2007 | TE: | AP | RLD: | No |
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