Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078606

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MITOXANTRONE HYDROCHLORIDE (MITOXANTRONE HYDROCHLORIDE)
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: MITOXANTRONE HYDROCHLORIDE
Proprietary Name: MITOXANTRONE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078606
Product Number: 001
Approval Date: May 14, 2008
Applicant Holder Full Name: FRESENIUS KABI ONCOLOGY PLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

MITOXANTRONE HYDROCHLORIDE (MITOXANTRONE HYDROCHLORIDE)
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: MITOXANTRONE HYDROCHLORIDE
Proprietary Name: MITOXANTRONE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078606
Product Number: 002
Approval Date: May 14, 2008
Applicant Holder Full Name: FRESENIUS KABI ONCOLOGY PLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

MITOXANTRONE HYDROCHLORIDE (MITOXANTRONE HYDROCHLORIDE)
EQ 30MG BASE/15ML (EQ 2MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: MITOXANTRONE HYDROCHLORIDE
Proprietary Name: MITOXANTRONE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 30MG BASE/15ML (EQ 2MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078606
Product Number: 003
Approval Date: May 14, 2008
Applicant Holder Full Name: FRESENIUS KABI ONCOLOGY PLC
Marketing Status:  Discontinued
Patent and Exclusivity Information