FDA.reportPublic FDA data

Application 021120

Type
NDA
Sponsor
SERONO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOVANTRONEMITOXANTRONE HYDROCHLORIDEINJECTABLE; INJECTIONEQ 2MG BASE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MitoxantroneMITOXANTRONE HYDROCHLORIDEFresenius Kabi USA, LLCfcb8ef8a-f770-4416-8fc5-fa01d98c8eee2024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOXANTRONE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23627ORIG2008-07-29
14429ORIG2004-06-10
4378ORIG2004-06-10
21460ORIG2004-04-12