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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
Citi
Johnson and Johnson
Chinese Patent Office
Boehringer Ingelheim
Teva
McKinsey
Medtronic

Generated: April 24, 2018

DrugPatentWatch Database Preview

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. Three suppliers are listed for this compound. Additional details are available on the mitoxantrone hydrochloride profile page.
Summary for 019297
Tradename:NOVANTRONE
Applicant:Emd Serono
Ingredient:mitoxantrone hydrochloride
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019297

Profile 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

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 23, 1987TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 23, 1987TE:RLD:Yes

Expired US Patents for NDA 019297

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-003 Dec 23, 1987 ➤ Sign Up ➤ Sign Up
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-001 Dec 23, 1987 ➤ Sign Up ➤ Sign Up
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-001 Dec 23, 1987 ➤ Sign Up ➤ Sign Up
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-001 Dec 23, 1987 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Merck
Julphar
Moodys
Cipla
Cerilliant
Deloitte
Harvard Business School
US Army

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