Details for New Drug Application (NDA): 076611
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NDA 076611 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 three suppliers. Additional details are available on the MITOXANTRONE HYDROCHLORIDE profile page.
The generic ingredient in MITOXANTRONE HYDROCHLORIDE is mitoxantrone hydrochloride. There is one drug master file entry for this compound. Three 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 is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.
Summary for 076611
| Tradename: | MITOXANTRONE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | mitoxantrone hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 076611
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 | ||||
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