FDA.reportPublic FDA data

Application 207308

Type
ANDA
Sponsor
AMNEAL PHARMS

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
65162-749RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-749RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-749RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-749RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-825RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-825RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-825RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-825RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-826RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-826RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-826RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent
65162-826RivastigmineRivastigmineAmneal Pharmaceuticals LLCANDACurrent