FDA.reportPublic FDA data

Application 021882

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXJADEDEFERASIROXTABLET, FOR SUSPENSION;ORAL125MGYesNo
002EXJADEDEFERASIROXTABLET, FOR SUSPENSION;ORAL250MGYesNo
003EXJADEDEFERASIROXTABLET, FOR SUSPENSION;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0468ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0469ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent
0078-0470ExjadedeferasiroxNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73251SUPPL2023-01-19
73179SUPPL2023-01-17
64106SUPPL2020-07-27
64105SUPPL2020-07-27
64096SUPPL2020-07-27
64087SUPPL2020-07-24
59479SUPPL2019-07-29
59478SUPPL2019-07-29
59445SUPPL2019-07-29
58963SUPPL2019-06-04
58874SUPPL2019-05-29
56880SUPPL2018-12-20
56879SUPPL2018-12-20
56733SUPPL2018-12-14
56732SUPPL2018-12-14
54195SUPPL2018-05-15
54176SUPPL2018-05-14
52704SUPPL2018-02-23
52680SUPPL2018-02-22
45071SUPPL2016-08-17
45080SUPPL2016-08-12
16521SUPPL2015-07-24
6384SUPPL2015-07-24
6383SUPPL2013-10-22
37827SUPPL2013-10-21
16520SUPPL2013-06-04
28782SUPPL2013-05-31
28781SUPPL2013-01-25
6382SUPPL2013-01-25
37826SUPPL2013-01-24
37825SUPPL2012-09-20
28780SUPPL2012-09-18
6381SUPPL2011-08-12
16519SUPPL2011-08-11
28779SUPPL2011-04-13
37824SUPPL2011-04-11
28778SUPPL2010-02-05
37823SUPPL2010-02-04
16518SUPPL2009-04-28
6379SUPPL2009-04-27
6380SUPPL2009-03-10
16517SUPPL2008-10-09
6378SUPPL2008-10-08
28777SUPPL2008-01-09
37822SUPPL2008-01-08
28776SUPPL2007-05-01
16516SUPPL2007-04-25
21857ORIG2006-01-10
28775ORIG2005-11-08
37821ORIG2005-11-03
52607SUPPL1900-01-01
52606SUPPL1900-01-01
52605SUPPL1900-01-01