FDA.reportPublic FDA data

Application 018927

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEGRETOLCARBAMAZEPINESUSPENSION;ORAL100MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0508TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0508TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0508TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0508TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0508TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0508TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0508TegretolcarbamazepineNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83623SUPPL 2025-10-02
83612SUPPL 2025-10-01
75461SUPPL 2023-09-14
75452SUPPL 2023-09-14
53452SUPPL2018-03-27
53420SUPPL2018-03-26
53148SUPPL2018-03-22
33650SUPPL2015-09-03
1129SUPPL2015-09-01
33652SUPPL2014-09-19
16100SUPPL2014-09-17
11368SUPPL2014-01-17
1133SUPPL2014-01-17
33654SUPPL2013-03-08
16102SUPPL2013-03-08
16104SUPPL2012-12-13
11369SUPPL2012-12-13
16103SUPPL2011-11-10
16101SUPPL2011-03-07
11367SUPPL2011-03-07
11366SUPPL2011-03-07
1131SUPPL2011-03-07
33653SUPPL2009-05-12
1132SUPPL2009-05-01
1130SUPPL2008-01-09
33651SUPPL2007-12-12
16099SUPPL2007-08-17
11365SUPPL2007-08-17
16098SUPPL2001-03-07
11364SUPPL2001-03-07