FDA.reportPublic FDA data

Application 016608

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEGRETOLCARBAMAZEPINETABLET;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0509TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0509TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0509TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0509TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0509TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0509TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0509TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
70518-1452TegretolcarbamazepineREMEDYREPACK INC.NDACurrent
70518-1452TegretolcarbamazepineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83624SUPPL 2025-10-02
83616SUPPL 2025-10-01
83613SUPPL 2025-10-01
75460SUPPL 2023-09-14
75453SUPPL 2023-09-14
53450SUPPL2018-03-27
53418SUPPL2018-03-26
53150SUPPL2018-03-22
10898SUPPL2015-09-03
13004SUPPL2015-09-01
10900SUPPL2014-09-19
459SUPPL2014-09-17
13006SUPPL2014-01-17
10902SUPPL2014-01-17
33181SUPPL2013-03-08
13007SUPPL2013-03-08
33182SUPPL2012-12-13
464SUPPL2012-12-13
463SUPPL2011-11-10
33179SUPPL2011-03-07
10901SUPPL2011-03-07
462SUPPL2011-03-07
460SUPPL2011-03-07
33180SUPPL2009-05-12
461SUPPL2009-05-01
13005SUPPL2008-01-09
44438SUPPL2007-12-31
10899SUPPL2007-12-12
33178SUPPL2007-08-17
458SUPPL2007-08-17
20053SUPPL2007-03-08
20052ORIG2004-12-08
33177SUPPL2001-03-07
457SUPPL2001-03-07