Details for New Drug Application (NDA): 076871
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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 076871
Tradename: | MITOXANTRONE HYDROCHLORIDE |
Applicant: | Hospira |
Ingredient: | mitoxantrone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 076871
Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076871
Suppliers and Packaging for NDA: 076871
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 076871 | ANDA | Hospira, Inc. | 61703-343 | 61703-343-18 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18) / 10 mL in 1 VIAL, MULTI-DOSE |
MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 076871 | ANDA | Hospira, Inc. | 61703-343 | 61703-343-65 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-65) / 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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