FDA.reportPublic FDA data

Application 019667

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SANDOSTATINOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.05MG BASE/MLYesYes
002SANDOSTATINOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.1MG BASE/MLYesYes
003SANDOSTATINOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.5MG BASE/MLYesYes
004SANDOSTATINOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 0.2MG BASE/MLYesYes
005SANDOSTATINOCTREOTIDE ACETATEINJECTABLE;INJECTIONEQ 1MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0180Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0180Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0180Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0180Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0180Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0180Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0181Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0181Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0181Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0181Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0181Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0181Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0182Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0182Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0182Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0182Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0182Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0182Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0183Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0183Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0078-0184Sandostatinoctreotide acetateNovartis Pharmaceuticals CorporationNDACurrent
0781-3164Octreotide AcetateOctreotide AcetateSandoz IncNDACurrent
0781-3165Octreotide AcetateOctreotide AcetateSandoz IncNDACurrent
0781-3166Octreotide AcetateOctreotide AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3167Octreotide AcetateOctreotide AcetateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3168Octreotide AcetateOctreotide AcetateSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79085SUPPL 2024-07-15
79060SUPPL 2024-07-15
76389SUPPL 2023-11-06
76376SUPPL 2023-11-06
72272SUPPL2022-10-07
72246SUPPL2022-10-05
69537SUPPL2021-12-13
69069SUPPL2021-10-22
67657SUPPL2021-06-02
67597SUPPL2021-05-26
58317SUPPL2019-04-12
58314SUPPL2019-04-12
11614SUPPL2015-03-12
17537SUPPL2015-02-24
1479SUPPL2014-02-11
33849SUPPL2012-03-27
17536SUPPL2012-03-27
1478SUPPL2010-02-05
33848SUPPL2010-02-04
11613SUPPL2008-08-29
1477SUPPL2008-08-28
33847SUPPL2005-09-08
1476SUPPL2005-09-08
17535SUPPL2003-02-10
11612SUPPL2003-01-17
1475SUPPL2003-01-17
17534SUPPL2002-07-24
1474SUPPL2002-07-24
40962SUPPL1999-02-19