FDA.reportPublic FDA data

Application 203255

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIGNIFOR LAR KITPASIREOTIDE PAMOATEFOR SUSPENSION;INTRAMUSCULAREQ 20MG BASE/VIALYesNo
002SIGNIFOR LAR KITPASIREOTIDE PAMOATEFOR SUSPENSION;INTRAMUSCULAREQ 40MG BASE/VIALYesNo
003SIGNIFOR LAR KITPASIREOTIDE PAMOATEFOR SUSPENSION;INTRAMUSCULAREQ 60MG BASE/VIALYesYes
004SIGNIFOR LAR KITPASIREOTIDE PAMOATEFOR SUSPENSION;INTRAMUSCULAREQ 10MG BASE/VIALYesNo
005SIGNIFOR LAR KITPASIREOTIDE PAMOATEFOR SUSPENSION;INTRAMUSCULAREQ 30MG BASE/VIALYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0641Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0641Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0641Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0641Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0641Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0641Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0642Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0642Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0642Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0642Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0642Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0642Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0643Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0643Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0643Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0643Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0643Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0643Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0741Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0741Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0741Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0741Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0741Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0748Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0748Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0748Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0748Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
0078-0748Signifor LARpasireotideNovartis Pharmaceuticals CorporationNDACurrent
55292-139Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-139Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-139Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-140Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-140Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-140Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-141Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-141Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-141Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-142Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-142Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-142Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-143Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-143Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent
55292-143Signifor LARpasireotideRecordati Rare Diseases Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79090SUPPL 2024-07-15
79067SUPPL 2024-07-15
63843SUPPL2020-07-10
63840SUPPL2020-07-10
58335SUPPL2019-04-15
58310SUPPL2019-04-12
57579SUPPL2019-02-13
57384SUPPL2019-01-30
54822SUPPL2018-07-06
54803SUPPL2018-07-06
54764SUPPL2018-07-05
52991SUPPL2018-03-15
52933SUPPL2018-03-13
24430ORIG2016-03-02
22918ORIG2016-03-02
40282ORIG2014-12-16
10193ORIG2014-12-16