Details for New Drug Application (NDA): 077356
✉ Email this page to a colleague
NDA 077356 describes MITOXANTRONE HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, and Rising, and is included in seven NDAs. It is available from two suppliers. Additional details are available on the MITOXANTRONE HYDROCHLORIDE profile page.
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.
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 077356
| Tradename: | MITOXANTRONE HYDROCHLORIDE |
| Applicant: | Meitheal |
| Ingredient: | mitoxantrone hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 077356
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | ||||
| Approval Date: | Apr 11, 2006 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) | ||||
| Approval Date: | Apr 11, 2006 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | ||||
| Approval Date: | Apr 11, 2006 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
