FDA.reportPublic FDA data

Application 021807

Type
NDA
Sponsor
FORTOVIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOLTAMOXTAMOXIFEN CITRATESOLUTION;ORALEQ 20MG BASE/10MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-682SOLTAMOXTAMOXIFEN CITRATEMayne PharmaNDACurrent
51862-682SOLTAMOXTAMOXIFEN CITRATEMayne PharmaNDACurrent
89141-123SoltamoxTAMOXIFEN CITRATEFortovia Therapeutics Inc.NDACurrent
89141-123SoltamoxTAMOXIFEN CITRATEMidatech Pharma US Inc.NDACurrent
89141-123SoltamoxTAMOXIFEN CITRATEFortovia Therapeutics Inc.NDACurrent
89141-123SoltamoxTAMOXIFEN CITRATEMidatech Pharma US Inc.NDACurrent
89141-123SoltamoxTAMOXIFEN CITRATEMidatech Pharma US Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58260SUPPL2019-04-09
58259SUPPL2019-04-09
58258SUPPL2019-04-09
55745SUPPL2018-10-01
55619SUPPL2018-09-26
55618SUPPL2018-09-26
21824ORIG2007-09-10
43783ORIG2007-02-21
28635ORIG2005-11-01
16406ORIG2005-11-01