FDA.reportPublic FDA data

Application 204403

Type
ANDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIVASTIGMINERIVASTIGMINEFILM, EXTENDED RELEASE;TRANSDERMAL4.6MG/24HRNoNo
002RIVASTIGMINERIVASTIGMINEFILM, EXTENDED RELEASE;TRANSDERMAL9.5MG/24HRNoNo
003RIVASTIGMINERIVASTIGMINEFILM, EXTENDED RELEASE;TRANSDERMAL13.3MG/24HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58718ORIG2019-05-15
32549ORIG2015-09-08
32550ORIG2015-07-23