FDA.report

Application 020981

Type
NDA
Sponsor
NOVARTIS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001HYCAMTINTOPOTECAN HYDROCHLORIDECAPSULE;ORALEQ 0.25MG BASEYesNo
002HYCAMTINTOPOTECAN HYDROCHLORIDECAPSULE;ORALEQ 1MG BASEYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0672HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent
0078-0672HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent
0078-0672HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent
0078-0672HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent
0078-0672HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent
0078-0673HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent
0078-0673HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent
0078-0673HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent
0078-0673HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent
0078-0673HYCAMTINtopotecanNovartis Pharmaceuticals CorporationNDACurrent

Documents

DocumentSubmission typeDate
55453SUPPL2018-09-12
55391SUPPL2018-09-06
35783SUPPL2014-06-23
26372SUPPL2014-06-19
14081SUPPL2011-10-12
3930SUPPL2011-10-12
14080SUPPL2010-07-06
3929SUPPL2010-07-02
44634ORIG2009-01-15
21325ORIG2009-01-15
26371ORIG2007-10-22
14079ORIG2007-10-12