FDA.reportPublic FDA data

Application 022074

Type
NDA
Sponsor
IPSEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOMATULINE DEPOTLANREOTIDE ACETATESOLUTION;SUBCUTANEOUSEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)YesYes
002SOMATULINE DEPOTLANREOTIDE ACETATESOLUTION;SUBCUTANEOUSEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)YesYes
003SOMATULINE DEPOTLANREOTIDE ACETATESOLUTION;SUBCUTANEOUSEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
15054-1060SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1060SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1060SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1060SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1060SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1090SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1090SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1090SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1090SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1090SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1120SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1120SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1120SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1120SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent
15054-1120SOMATULINE DEPOTlanreotide acetateIpsen Biopharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79087SUPPL 2024-07-15
79066SUPPL 2024-07-15
73609SUPPL 2023-02-27
73608SUPPL 2023-02-27
73142SUPPL2023-01-11
73139SUPPL2023-01-11
72844SUPPL2022-12-09
72839SUPPL2022-12-09
72414SUPPL2022-10-19
58320SUPPL2019-04-12
58307SUPPL2019-04-12
57151SUPPL2019-01-09
56860SUPPL2018-12-20
53728SUPPL2018-04-18
53719SUPPL2018-04-18
52723SUPPL2018-02-26
52695SUPPL2018-02-23
49779SUPPL2017-09-19
49775SUPPL2017-09-19
16900SUPPL2015-01-09
6829SUPPL2014-12-24
6830SUPPL2014-12-17
16901SUPPL2014-12-16
16898SUPPL2014-10-29
29207SUPPL2013-12-05
16899SUPPL2013-12-03
29206SUPPL2011-03-08
16897SUPPL2011-03-07
42409ORIG2007-11-06
29205ORIG2007-09-04
16896ORIG2007-09-04