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Last Updated: November 4, 2024

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. Two 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
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20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 23, 1987TE:RLD:Yes

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25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019297-001 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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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