Details for New Drug Application (NDA): 078606
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The generic ingredient in MITOXANTRONE HYDROCHLORIDE is mitoxantrone hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.
Summary for 078606
Tradename: | MITOXANTRONE HYDROCHLORIDE |
Applicant: | Fresenius Kabi Oncol |
Ingredient: | mitoxantrone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 078606
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | ||||
Approval Date: | May 14, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) | ||||
Approval Date: | May 14, 2008 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | ||||
Approval Date: | May 14, 2008 | TE: | RLD: | No |
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