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Details for New Drug Application (NDA): 019297

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NDA 019297 describes NOVANTRONE, which is a drug marketed by Emd Serono and is included in one NDA. Additional details are available on the NOVANTRONE profile page.

The generic ingredient in NOVANTRONE is mitoxantrone hydrochloride. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.

Summary for NDA: 019297

Tradename:
NOVANTRONE
Applicant:
Emd Serono
Ingredient:
mitoxantrone hydrochloride
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/10ML (EQ 2MG BASE/ML)
Approval Date:Dec 23, 1987TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)
Approval Date:Dec 23, 1987TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 30MG BASE/15ML (EQ 2MG BASE/ML)
Approval Date:Dec 23, 1987TE:RLD:No

Expired Orange Book Patents for NDA: 019297

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-003Dec 23, 19874,820,738► subscribe
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-001Dec 23, 19874,138,415► subscribe
Emd Serono
NOVANTRONE
mitoxantrone hydrochloride
INJECTABLE;INJECTION019297-001Dec 23, 19874,617,319► subscribe
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