FDA.reportPublic FDA data

Application 021014

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRILEPTALOXCARBAZEPINETABLET;ORAL150MGYesNo
002TRILEPTALOXCARBAZEPINETABLET;ORAL300MGYesNo
003TRILEPTALOXCARBAZEPINETABLET;ORAL600MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
55289-007TrileptaloxcarbazepinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-007TrileptaloxcarbazepinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-007TrileptaloxcarbazepinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-007TrileptaloxcarbazepinePD-Rx Pharmaceuticals, Inc.NDACurrent
70518-1300TrileptaloxcarbazepineREMEDYREPACK INC.NDACurrent
70518-1300TrileptaloxcarbazepineREMEDYREPACK INC.NDACurrent
70518-1349TrileptaloxcarbazepineREMEDYREPACK INC.NDACurrent
70518-1349TrileptaloxcarbazepineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83527SUPPL 2025-09-26
83526SUPPL 2025-09-26
83435SUPPL 2025-09-25
81207SUPPL 2025-02-11
81206SUPPL 2025-02-11
79543SUPPL 2024-09-05
79541SUPPL 2024-09-05
57415SUPPL2019-02-04
57136SUPPL2019-01-08
53501SUPPL2018-03-28
53242SUPPL2018-03-23
53236SUPPL2018-03-23
50489SUPPL2017-11-27
50460SUPPL2017-11-20
47726SUPPL2017-03-28
47668SUPPL2017-03-24
35890SUPPL2014-07-08
4044SUPPL2014-07-08
14165SUPPL2014-06-10
4045SUPPL2014-06-10
35889SUPPL2013-02-12
4043SUPPL2013-02-12
26490SUPPL2011-11-14
35888SUPPL2011-03-21
35887SUPPL2011-03-21
35885SUPPL2011-03-21
35884SUPPL2011-03-21
35883SUPPL2011-03-21
14164SUPPL2011-03-21
14163SUPPL2011-03-21
26489SUPPL2011-03-08
26487SUPPL2011-03-08
26486SUPPL2011-03-08
4042SUPPL2011-03-08
4041SUPPL2011-03-08
4040SUPPL2011-03-08
4038SUPPL2011-03-08
35886SUPPL2009-05-12
26488SUPPL2009-05-04
4039SUPPL2007-09-06
24144ORIG2007-03-16
41877SUPPL2006-05-31
26485SUPPL2005-11-18
26484SUPPL2005-11-01
14162SUPPL2005-10-28
14161SUPPL2005-03-30
4037SUPPL2005-03-30
35882SUPPL2003-08-15
4034SUPPL2003-08-15
4036SUPPL2003-04-15
4035SUPPL2002-04-01
41876ORIG2002-02-28
35881ORIG1999-01-10
26483ORIG1999-01-10
52101SUPPL1900-01-01
52099SUPPL1900-01-01
52096SUPPL1900-01-01
52094SUPPL1900-01-01