Application 019297

Type
NDA
Sponsor
EMD SERONO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOVANTRONEMITOXANTRONE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 20MG BASE/10ML (EQ 2MG BASE/ML)YesNo
002NOVANTRONEMITOXANTRONE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003NOVANTRONEMITOXANTRONE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43618SUPPL2012-03-27
11472SUPPL2012-03-27
17353SUPPL2012-03-26
33719SUPPL2010-06-24
11471SUPPL2010-06-24
17352SUPPL2010-06-16
1278SUPPL2010-06-16
17351SUPPL2009-02-13
1277SUPPL2009-02-13
33718SUPPL2009-02-12
11470SUPPL2009-02-12
23548ORIG2008-07-29
40884ORIG2008-04-04
1276SUPPL2007-04-20
11469SUPPL2005-04-28
1275SUPPL2005-04-28
17350SUPPL2003-01-13
1274SUPPL2003-01-13
1273SUPPL2003-01-13
1272SUPPL2002-02-20
40886SUPPL2000-02-04
40885SUPPL1997-11-20