FDA.reportPublic FDA data

Application 200677

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIGNIFORPASIREOTIDE DIASPARTATESOLUTION;SUBCUTANEOUSEQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)YesNo
002SIGNIFORPASIREOTIDE DIASPARTATESOLUTION;SUBCUTANEOUSEQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)YesNo
003SIGNIFORPASIREOTIDE DIASPARTATESOLUTION;SUBCUTANEOUSEQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0633SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0633SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0633SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0633SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0633SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0634SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0634SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0634SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0634SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0634SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0634SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0635SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0635SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0635SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0635SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0635SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0635SigniforpasireotideNovartis Pharmaceuticals CorporationNDACurrent
55292-131SigniforpasireotideRecordati Rare Diseases, Inc.NDACurrent
55292-131SigniforpasireotideRecordati Rare Diseases, Inc.NDACurrent
55292-131SigniforpasireotideRecordati Rare Diseases, Inc.NDACurrent
55292-132SigniforpasireotideRecordati Rare Diseases, Inc.NDACurrent
55292-132SigniforpasireotideRecordati Rare Diseases, Inc.NDACurrent
55292-132SigniforpasireotideRecordati Rare Diseases, Inc.NDACurrent
55292-133SigniforpasireotideRecordati Rare Diseases, Inc.NDACurrent
55292-133SigniforpasireotideRecordati Rare Diseases, Inc.NDACurrent
55292-133SigniforpasireotideRecordati Rare Diseases, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79089SUPPL 2024-07-15
79088SUPPL 2024-07-15
61585SUPPL2020-01-16
61583SUPPL2020-01-16
61581SUPPL2020-01-16
58334SUPPL2019-04-15
58309SUPPL2019-04-12
58308SUPPL2019-04-12
57578SUPPL2019-02-13
57383SUPPL2019-01-30
52990SUPPL2018-03-15
52932SUPPL2018-03-13
40040SUPPL2015-03-19
32047SUPPL2015-03-18
9842SUPPL2013-02-15
43353ORIG2013-01-22
24387ORIG2013-01-22
9841ORIG2012-12-21
23473ORIG2012-12-18
40039ORIG2012-12-17