FDA.reportPublic FDA data

Application 203901

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL5MGNoNo
002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL10MGNoNo
003DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45963-303dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-303dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-303dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-303dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-303dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-303dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-304dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-304dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-304dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-304dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-304dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-304dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-305dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-305dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-305dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-305dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-305dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
45963-305dextroamphetamine sulfatedextroamphetamine sulfateActavis Pharma, Inc.ANDACurrent
51862-344dextroamphetamine sulfatedextroamphetamine sulfateMayne Pharma Inc.ANDACurrent
51862-344dextroamphetamine sulfatedextroamphetamine sulfateMayne Pharma Inc.ANDACurrent
51862-344dextroamphetamine sulfatedextroamphetamine sulfateMayne Pharma Inc.ANDACurrent
51862-345dextroamphetamine sulfatedextroamphetamine sulfateMayne Pharma Inc.ANDACurrent
51862-345dextroamphetamine sulfatedextroamphetamine sulfateMayne Pharma Inc.ANDACurrent
51862-345dextroamphetamine sulfatedextroamphetamine sulfateMayne Pharma Inc.ANDACurrent
51862-346dextroamphetamine sulfatedextroamphetamine sulfateMayne Pharma Inc.ANDACurrent
51862-346dextroamphetamine sulfatedextroamphetamine sulfateMayne Pharma Inc.ANDACurrent
51862-346dextroamphetamine sulfatedextroamphetamine sulfateMayne Pharma Inc.ANDACurrent