Details for New Drug Application (NDA): 077496
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NDA 077496 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 are seven drug master file entries 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 are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.
Summary for 077496
| Tradename: | MITOXANTRONE HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | mitoxantrone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 077496
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077496
Suppliers and Packaging for NDA: 077496
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 077496 | ANDA | Fresenius Kabi USA, LLC | 63323-132 | 63323-132-10 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-10) / 10 mL in 1 VIAL, MULTI-DOSE |
| MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 077496 | ANDA | Fresenius Kabi USA, LLC | 63323-132 | 63323-132-12 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-12) / 12.5 mL in 1 VIAL, MULTI-DOSE |
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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