FDA.reportPublic FDA data

Application 050716

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEORALCYCLOSPORINESOLUTION;ORAL100MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0274NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0274NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0274NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0274NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent
0078-0274NeoralcyclosporineNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75581SUPPL 2023-09-27
75575SUPPL 2023-09-27
18100SUPPL2019-03-07
8090SUPPL2015-04-02
18099SUPPL2013-05-09
30347SUPPL2013-05-07
8089SUPPL2012-09-05
18098SUPPL2012-08-31
8087SUPPL2009-11-12
8088SUPPL2009-11-09
39169SUPPL2009-10-14
18097SUPPL2009-10-01
18096SUPPL2007-08-02
8086SUPPL2007-08-02
30346SUPPL2006-03-23
18095SUPPL2006-03-10
18094SUPPL2005-07-26
8085SUPPL2005-07-26
39168SUPPL2004-03-03
18093SUPPL2004-03-03
30345SUPPL2004-02-27
8084SUPPL2004-02-27
39167SUPPL2002-06-12
30344SUPPL2002-06-12
18092SUPPL2002-06-12
8083SUPPL2002-06-12