FDA.reportPublic FDA data

Application 020823

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003EXELONRIVASTIGMINE TARTRATECAPSULE;ORALEQ 1.5MG BASEYesNo
004EXELONRIVASTIGMINE TARTRATECAPSULE;ORALEQ 3MG BASEYesNo
005EXELONRIVASTIGMINE TARTRATECAPSULE;ORALEQ 4.5MG BASEYesNo
006EXELONRIVASTIGMINE TARTRATECAPSULE;ORALEQ 6MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0323Exelonrivastigmine tartrateNovartis Pharmaceuticals CorporationNDACurrent
0078-0324Exelonrivastigmine tartrateNovartis Pharmaceuticals CorporationNDACurrent
0078-0325Exelonrivastigmine tartrateNovartis Pharmaceuticals CorporationNDACurrent
0078-0326Exelonrivastigmine tartrateNovartis Pharmaceuticals CorporationNDACurrent
0781-2614Rivastigmine Tartraterivastigmine tartrateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2615Rivastigmine Tartraterivastigmine tartrateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2616Rivastigmine Tartraterivastigmine tartrateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-2617Rivastigmine Tartraterivastigmine tartrateSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56930SUPPL2018-12-21
56795SUPPL2018-12-19
45808SUPPL2016-11-04
45799SUPPL2016-11-03
35420SUPPL2015-02-05
35419SUPPL2013-10-08
35418SUPPL2013-10-08
35417SUPPL2013-10-08
13494SUPPL2013-10-08
25921SUPPL2013-10-04
25920SUPPL2013-10-04
3430SUPPL2013-10-04
3426SUPPL2013-10-04
20981SUPPL2007-06-18
3429SUPPL2006-07-03
13493SUPPL2006-06-28
20982SUPPL2006-06-27
3428SUPPL2004-09-24
3427SUPPL2004-05-07
13492SUPPL2001-01-05
20980ORIG2000-04-21
13491ORIG2000-04-21
3425ORIG2000-04-21