FDA.reportPublic FDA data

Application 050715

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEORALCYCLOSPORINECAPSULE;ORAL25MGYesNo
002NEORALCYCLOSPORINECAPSULE;ORAL100MGYesYes
003NEORALCYCLOSPORINECAPSULE;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0246NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0246NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0246NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0246NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0246NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0248NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0248NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0248NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0248NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0248NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75580SUPPL 2023-09-27
75574SUPPL 2023-09-27
39166SUPPL2019-03-07
8082SUPPL2015-04-02
18091SUPPL2013-05-09
30343SUPPL2013-05-07
8081SUPPL2012-09-05
18090SUPPL2012-08-31
8079SUPPL2009-11-12
8080SUPPL2009-11-09
39165SUPPL2009-10-14
18089SUPPL2009-10-01
18088SUPPL2007-08-02
8078SUPPL2007-08-02
30342SUPPL2006-03-23
18087SUPPL2006-03-10
30341SUPPL2005-07-26
18086SUPPL2005-07-26
30340SUPPL2004-06-09
18085SUPPL2004-06-09
8077SUPPL2004-06-09
39164SUPPL2004-03-03
39163SUPPL2002-06-12
30339SUPPL2002-06-12
18084SUPPL2002-06-12
8076SUPPL2002-06-12